Prosthetic capsular devices, systems, and methods

ABSTRACT

A prosthetic capsular device configured to be inserted in a natural capsular bag of an eye after removal of a lens includes a housing structure capable of containing an intraocular device. The housing structure includes a posterior side, an anterior side opposite the posterior side, lateral sides extending between the posterior side and the anterior side, and a cavity at least partially defined by the posterior side, the anterior side, and the lateral sides. The posterior side includes a refractive surface and an opening radially outward of the refractive surface. The anterior side includes an aperture capable of allowing at least one of insertion, removal, and replacement of an intraocular device. The cavity is capable of containing an intraocular device.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application claims the benefit under 35 U.S.C. § 119(c) ofU.S. Provisional Application No. 62/346,355, filed Jun. 6, 2016, andentitled “PROSTHETIC CAPSULAR DEVICES, SYSTEMS, AND METHODS,” which ishereby incorporated herein by reference in its entirety under 37 C.F.R.§ 1.57.

BACKGROUND Technical Field

The present application relates to prosthetic capsular devices includingwearable electronic technology device(s), and methods for insertion intothe eye.

Description

Cataract surgery is one of the most successfully and most frequentlyperformed surgical procedures in the United States. Each year, millionsof people achieve a dramatic improvement in their visual function thanksto this procedure. With the increasing proportion of the U.S. populationreaching their retirement years, there is expected to be an almostdoubling of the demand for cataract surgery over the next twenty yearsfrom 3.3 million to over 6 million annually. In response to theincreased demand, more ophthalmologists may be trained and certified toperform cataract surgery, and each trained and certified ophthalmologistmay perform more cataract surgeries each year.

In addition to the increase in demand for cataract surgery,technological advances have increased patient expectations for thesurgery. The procedure takes a short amount of time to perform, andpatients expect quick recovery of visual function. Patients are alsoasking their ophthalmologist to give them the restoration of moreyouthful vision without glasses through the use multifocal intraocularlenses, presbyopia correcting lenses, toric lenses, and monovision, toname a few. Despite accurate preoperative measurements and excellentsurgical technique, the desired refractive outcome requires a dose ofgood fortune as there are numerous uncontrolled variables involved. Asmany as 20-50% of post-operative cataract patients may benefit fromglasses or follow-up refractive surgical enhancements to achieve theirdesired refractive endpoint. The reason for this high amount ofrefractive unpredictability is believed to be the final resting positionof the lens implant in the eye, mathematically expressed as theeffective lens position (ELP), which can be quite variable andunpredictable in the current state of cataract surgery. Recently,hundreds of millions of dollars have been invested into developinghighly sophisticated femtosecond laser systems that are able to moreprecisely control the size and shape of the capsulotomy and cornealincisions with the stated goal of lessening the variability of the ELPand thus aiding in better refractive outcomes. Unfortunately, theincreased precision of the femtosecond laser systems have not been ableto account for the major problem plaguing the variability of the ELP,which is the volumetric difference between the cataract, naturalcapsular bag, and intraocular lens implant (IOL).

A device and method that helps provide the desired refractive endpointin cataract surgery is described in PCT Published Patent Application No.WO 2013/126380, Wortz, published on Aug. 29, 2013, which is incorporatedherein by reference in its entirety.

All patents and other documents referred to in this application areincorporated by reference herein in their entirety.

SUMMARY

Over the past few years, there has been a major increase in the presenceof and reliance on small electronic devices, such as smartphones andrelated wearable technology, which can provide the user with functionssuch as internet access, computational ability, computer functionality,e-mail, games, and global positioning system (GPS) function. Some ofthese devices are being miniaturized and are sometimes worn on the body,such as Google Glass, Microsoft HoloLens, and other head-mounteddisplays. Additionally, wearable technology that provides biometric datasuch as blood glucose levels, electrolyte balance, heart rate,electrocardiogram (EKG), intraocular pressure, sensing ciliary musclecontraction for accommodation stimulus, dynamic pupil change, andretinal prostheses have been developed to assist in technology-assistedhealth care. Such body-mounted devices can be awkward to wear and someusers might prefer the positioning of the device in the body. Certainimplementations described herein can provide methods and devices forplacing an electronic device in the eye.

Certain implementations described herein relate to prosthetic capsulardevices (e.g., bags as defined in WO 2013/126380) that can be insertedinto an eye. A prosthetic capsular device may comprise an anteriorsurface including an opening, and a posterior surface. At least aportion of the posterior surface includes or is a refractive surface.The device includes a wearable electronic technology device (e.g., atechnology device). The prosthetic capsular device or a systemcomprising the prosthetic capsular device may include an intraocularlens or features similar to an IOL, such as may be used in cataractsurgery to replace the natural lens. The technology device and theintraocular lens may be positioned (e.g., in, around, etc. theprosthetic capsular device) such that the technology device does notinterfere with (e.g., block, distort) the sight lines through theintraocular lens.

A retinal prosthesis may be positioned in a prosthetic capsular device,and data collected by the prosthesis may be remotely transmitted to theoptic nerve and/or optionally transmitted directly to the visual cortex,for example wirelessly. In some implementations in which the retinalprosthesis can function as the end receptor of light, the retinalprosthesis may interfere with (e.g., block, distort) the sight linesthrough the IOL.

A method for inserting a wearable technology device (e.g., a technologydevice) into an eye of a patient may comprise surgically removing a lensor cataract from a natural capsule, leaving the natural capsule in anempty state; inserting a prosthetic capsular device into the eye of thepatient (e.g., the prosthetic capsular device including an anteriorsurface having an opening, and a posterior surface, wherein at least aportion of the posterior surface includes or is a refractive surface);and inserting an electronic technology device into the prostheticcapsular device.

An intraocular lens may also be inserted into the prosthetic capsulardevice, and may be placed in the prosthetic capsular device such thatthe technology device does not interfere with (e.g., block, distort)sight lines through the intraocular lens, except optionally in the caseof a retinal prosthesis.

In some embodiments, a prosthetic capsular device configured to beinserted in a natural capsular bag of an eye after removal of a lenscomprises a housing structure capable of containing an intraoculardevice. The housing structure includes a posterior side, an anteriorside opposite the posterior side, lateral sides extending between theposterior side and the anterior side, and a cavity at least partiallydefined by the posterior side, the anterior side, and the lateral sides.The posterior side includes a refractive surface and an opening radiallyoutward of the refractive surface. The anterior side includes anaperture capable of allowing at least one of insertion, removal, andreplacement of an intraocular device. The cavity is capable ofcontaining an intraocular device.

The posterior side may include a plurality of openings including theopening and a second opening. The second opening may be a mirror imageof the opening along a major axis of the device. The second opening maybe a mirror image of the opening along a minor axis of the device. Theopening may have a thickness between 0 mm and 1 mm. The opening maycomprise an arc. The arc may be between 30° and 120°. The opening maycomprise a slit. The aperture may be oblong. The opening may be radiallyinward of the aperture. The device may comprise a ring structureincluding a ring structure portion extending radially outward fromproximate one of the lateral sides. The ring structure may comprise aplurality of ring structure portions including the ring structureportion. The ring structure portion may include an anterior-posteriorhole proximate to a terminal end. The housing structure may comprise afirst material. The ring structure may comprise a second materialdifferent than the first material. The first material may comprisesilicone, hydrogel, collamer, acrylic, and/or acrylic derivatives. Thesecond material may comprise polyimide, polypropylene, nylon, and/orpolyvinylidene fluoride (PVDF). The refractive surface may have arefractive power between −35 D and +35 D. The refractive surface mayhave a refractive power less than −35 D. The refractive surface may havea refractive power greater than +35 D. The housing structure maycomprise a posterior fin extending into the cavity. The housingstructure may comprise a bulge extending into the cavity.

In some embodiments, a prosthetic capsular device that is configured tobe inserted in an eye comprises a housing structure and a ringstructure. The housing structure comprises a first material. The housingstructure includes a first flat side, a second flat side opposite thefirst flat side, a third arcuate side extending between the first end ofthe first flat side and the first end of the second flat side, a fourtharcuate side extending between the second end of the first flat side andthe second end of the second flat side and the fourth arcuate sideopposite the third arcuate side, a posterior side, an anterior sideopposite the posterior side, and a longitudinal axis. The first flatside includes a first end and a second end. The second flat sideincludes a first end and a second end. The posterior side includes arefractive surface and a posterior fin. The anterior side includes anopening and a round lip around the opening. The first flat side, thesecond flat side, the third arcuate side, the fourth arcuate side, theposterior side, and the anterior side at least partially define a cavityconfigured to contain an intraocular device (e.g., an IOL). The ringstructure comprises a second material different than the first material.The ring structure is transverse to the longitudinal axis and at aposition along the longitudinal axis. The ring structure includes afirst ring structure portion extending from proximate to the first endof the first flat side radially outward and towards the second end ofthe first flat side, a second ring structure portion extending fromproximate to the second end of the first flat side radially outward andtowards the first end of the first flat side, a third ring structureportion extending from proximate to the first end of the second flatside radially outward and towards the first end of the second flat side,and a fourth ring structure portion extending from proximate to thesecond end of the second flat side radially outward and towards thefirst end of the second flat side. The first ring structure portion isanchored in the first flat side and the third arcuate side. The secondring structure portion is anchored in the first flat side and the fourtharcuate side. The third ring structure portion is anchored in the secondflat side and the third arcuate side. The fourth ring structure portionis anchored in the second flat side and the fourth arcuate side. Each ofthe first ring structure portion, the second ring structure portion, thethird ring structure portion, and the fourth ring structure portionincludes an anterior-posterior opening (e.g., an eyelet) proximate to aterminal end. The housing structure further comprises a bulge extendingradially outward from anchor points of the ring structure. Each of thefirst flat side, the second flat side, the third arcuate side, and thefourth arcuate side includes a first portion extending parallel to thelongitudinal axis from the posterior side towards the anterior side toat least the position of the ring structure along the longitudinal axisand a second portion extending radially inwardly from the first portiontowards the lip of the anterior side. The first material may comprisesilicone. The second material may comprise polyimide. The refractivesurface may have a refractive power between −35 D and +35 D. The openingmay be oblong.

In some embodiments, a prosthetic capsular device that is configured tobe inserted in an eye comprises a housing structure and a ringstructure. The housing structure includes a first flat side, a secondflat side opposite the first side, a third arcuate side extendingbetween the first end of the first flat side and the first end of thesecond flat side, a fourth arcuate side extending between the second endof the first flat side and the second end of the second flat side andthe fourth arcuate side opposite the third arcuate side, a posteriorside including a refractive surface, an anterior side opposite theposterior side, and a longitudinal axis. The first flat side includes afirst end and a second end. The second flat side includes a first endand a second end. The anterior side includes an opening. The first flatside, the second flat side, the third arcuate side, the fourth arcuateside, the posterior side, and the anterior side at least partiallydefine a cavity configured to contain an intraocular device (e.g., anIOL). The ring structure includes a first ring structure portionextending from proximate to the first end of the first flat sideradially outward and towards the second end of the first flat side, asecond ring structure portion extending from proximate to the second endof the first flat side radially outward and towards the first end of thefirst flat side, a third ring structure portion extending from proximateto the first end of the second flat side radially outward and towardsthe first end of the second flat side, and a fourth ring structureportion extending from proximate to the second end of the second flatside radially outward and towards the first end of the second flat side.The housing structure may comprise a first material. The ring structuremay comprise a second material different than the first material. Thefirst material may comprise silicone. The second material may comprisepolyimide. The refractive surface may have a refractive power between−35 D and +35 D. One, two, three, or each of the first flat side, thesecond flat side, the third arcuate side, and the fourth arcuate sidemay include a portion extending parallel to the longitudinal axis fromthe posterior side towards the anterior side. One, two, three, or eachof the first flat side, the second flat side, the third arcuate side,and the fourth arcuate side may include a second portion extendingradially inwardly from the first portion towards the opening of theanterior side. The housing structure may comprise a bulge extendingradially outward from anchor points of the ring structure. One, two,three, or each of the first ring structure portion, the second ringstructure portion, the third ring structure portion, and the fourth ringstructure portion may include an anterior-posterior opening (e.g., aneyelet) proximate to a terminal end.

In some embodiments, a prosthetic capsular device that is configured tobe inserted in an eye comprises a housing structure and a ringstructure. The housing structure includes a first side, a second sideopposite the first side, a third side extending between the first end ofthe first side and the first end of the second side, a fourth sideextending between the second end of the first side and the second end ofthe second side and the fourth side opposite the third side, a posteriorside including a refractive surface, an anterior side opposite theposterior side, and a longitudinal axis. The first side includes a firstend and a second end. The second side includes a first end and a secondend. The anterior side includes an opening. The first side, the secondside, the third side, the fourth side, the posterior side, and theanterior side at least partially define a cavity configured to containan intraocular device (e.g., an IOL). The ring structure includes a ringstructure portion extending radially outward from proximate one of thefirst end of the first side, the second end of the first side, the firstend of the second side, and the second end of the second side. Thehousing structure may comprise a first material. The ring structure maycomprise a second material different than the first material. The firstmaterial may comprise silicone. The second material may comprisepolyimide. The refractive surface may have a refractive power between−35 D and +35 D. The opening may be oblong. The device may furthercomprise a lip around the opening. One, two, three, or each of the firstside, the second side, the third side, and the fourth side may include aportion extending parallel to the longitudinal axis from the posteriorside towards the anterior side. One, two, three, or each of the firstside, the second side, the third side, and the fourth side may include asecond portion extending radially inwardly from the first portiontowards the opening of the anterior side. The posterior side maycomprise a posterior fin. The housing structure may comprise a bulgeextending radially outward from anchor points of the ring structure. Thering structure may comprise a plurality of ring structure portionsincluding the ring structure portion. The ring structure portion may bea first ring structure portion extending from proximate to the first endof the first flat side radially outward and towards the second end ofthe first flat side. The plurality of ring structure portions mayinclude a second ring structure portion extending from proximate to thesecond end of the first flat side radially outward and towards the firstend of the first flat side, a third ring structure portion extendingfrom proximate to the first end of the second flat side radially outwardand towards the first end of the second flat side, and a fourth ringstructure portion extending from proximate to the second end of thesecond flat side radially outward and towards the first end of thesecond flat side. The ring structure portion may include ananterior-posterior opening (e.g., an eyelet) proximate to a terminalend.

The methods summarized above and set forth in further detail below maydescribe certain actions taken by a practitioner; however, it should beunderstood that these steps can also include the instruction of thoseactions by another party. Thus, actions such as “inserting anintraocular lens into a prosthetic capsular device” include “instructingthe insertion of an intraocular lens into a prosthetic capsular device.”

BRIEF DESCRIPTION OF THE DRAWINGS

A better understanding of the devices and methods described herein willbe appreciated upon reference to the following description inconjunction with the accompanying drawings, wherein:

FIG. 1 depicts a cross-sectional side view of an eye including anexample of a prosthetic capsular device including an IOL;

FIG. 2 depicts a side view of the example prosthetic capsular deviceshown in FIG. 1;

FIG. 3 depicts an anterior plan view of the example prosthetic capsulardevice shown in FIG. 1;

FIG. 4A is a flow chart of an example method for inserting andpositioning a prosthetic capsular device into an eye;

FIGS. 4B-4G are photos of an example method for inserting andpositioning a prosthetic capsular device into an eye;

FIG. 4H is a side view of an example prosthetic capsular device;

FIG. 4I is an anterior view of the prosthetic capsular device of FIG.4H;

FIG. 4J is a cross-sectional view of the prosthetic capsular device ofFIG. 4H along the line 4J-4J of FIG. 4I;

FIG. 5 depicts a cross-sectional side view of an eye including anotherexample of a prosthetic capsular device containing including an IOL;

FIG. 6 depicts a side view of the example prosthetic capsular deviceshown in FIG. 5;

FIG. 7 depicts an anterior plan view of the example prosthetic capsulardevice shown in FIG. 5;

FIG. 8 depicts a side view of an example prosthetic capsular devicecomprising an outer surface including, around a perimeter of the outersurface, a continuous outer rim of tabs (e.g., comprising silicone) eachtab including an opening in a center of the tab, and the capsular deviceincluding an internal lip configured to hold haptics of an IOL;

FIG. 9A depicts a side view of another example prosthetic capsulardevice;

FIG. 9B depicts a side cross-sectional view of the prosthetic capsulardevice of FIG. 9A;

FIG. 9C depicts a posterior plan view of the prosthetic capsular deviceof FIG. 9A;

FIG. 9D depicts an anterior side perspective view of the prostheticcapsular device of FIG. 9A;

FIG. 10A depicts a side view of yet another example prosthetic capsulardevice;

FIG. 10B depicts a side cross-sectional view of the prosthetic capsulardevice of FIG. 10A;

FIG. 10C depicts a posterior plan view of the prosthetic capsular deviceof FIG. 10A;

FIG. 10D depicts an anterior side perspective view of the prostheticcapsular device of FIG. 10A;

FIG. 11A depicts a side view of still another example prostheticcapsular device;

FIG. 11B depicts a side cross-sectional view of the prosthetic capsulardevice of FIG. 11A;

FIG. 11C depicts a posterior plan view of the prosthetic capsular deviceof FIG. 11A;

FIG. 11D depicts a posterior plan view of still yet another exampleprosthetic capsular device;

FIG. 11E depicts an anterior side perspective view of the prostheticcapsular device of FIG. 11A;

FIG. 12A depicts a cross-sectional view of an eye including an exampleprosthetic capsular device containing including both a technology deviceand an IOL;

FIG. 12B depicts a front view of an example intraocular lens usable inthe example prosthetic capsular device shown in FIG. 12A in which thetechnology device surrounds the outer edge of the IOL (e.g., surroundsthe outer edge of the optical surface of the IOL);

FIG. 12C depicts a top front perspective of the example intraocular lensof FIG. 12B;

FIG. 13 illustrates a side cross-sectional side view of an eye includingan example of a prosthetic capsular device and an IOL;

FIG. 14A illustrates an anterior plan view of the example prostheticcapsular device of FIG. 13 with an optional secondary IOL positionedinside the prosthetic capsular device;

FIG. 14B illustrates an anterior plan view of another example prostheticcapsular device with an optional secondary IOL positioned inside theprosthetic capsular device;

FIG. 15 illustrates a side perspective view of the example prostheticdevice of FIG. 13;

FIG. 16 illustrates a side perspective view of another example of aprosthetic capsular device;

FIG. 17 illustrates a side perspective view of yet another example of aprosthetic capsular device;

FIG. 18 illustrates a side perspective view of still another example ofa prosthetic capsular device;

FIG. 19 illustrates an anterior plan view of yet still another exampleof a prosthetic capsular device with an optional secondary IOLpositioned inside the prosthetic capsular device;

FIG. 20 is an anterior plan view of another example of a prostheticcapsular device with an optional secondary IOL positioned inside theprosthetic capsular device;

FIG. 21 is an anterior plan view of yet another example of a prostheticcapsular device with an optional secondary IOL positioned inside theprosthetic capsular device;

FIG. 22A is an anterior plan view of still another example of aprosthetic capsular device with an optional secondary IOL positionedinside the prosthetic capsular device;

FIG. 22B is an anterior plan view of still yet another example of aprosthetic capsular device with an optional secondary IOL positionedinside the prosthetic capsular device;

FIG. 22C is a side perspective view of the example prosthetic capsulardevice of FIG. 22B with an optional secondary IOL positioned inside theprosthetic capsular device;

FIG. 23 illustrates a side cross-sectional side view of an eye includingan example of a prosthetic capsular device and an IOL;

FIG. 24 illustrates an anterior plan view of the example prostheticcapsular device of FIG. 23 with an optional secondary IOL positionedinside the prosthetic capsular device;

FIG. 25 illustrates a side perspective of the example prostheticcapsular device of FIG. 23 with an optional secondary IOL positionedinside the prosthetic capsular device;

FIG. 26 illustrates a side cross-sectional side view if an eye includinganother example of a prosthetic capsular device and an IOL;

FIG. 27 illustrates an anterior plan view of the example prostheticcapsular device of FIG. 26 with an optional secondary IOL positionedinside the prosthetic capsular device;

FIG. 28 illustrates a side perspective of the example prostheticcapsular device of FIG. 26 with an optional secondary IOL positionedinside the prosthetic capsular device;

FIG. 29 illustrates an anterior plan view of another example of aprosthetic capsular device with an optional secondary IOL positionedinside the prosthetic capsular device;

FIG. 30 illustrates a side perspective view of the example prostheticcapsular device of FIG. 29 with an optional secondary IOL positionedinside the prosthetic capsular device;

FIG. 31 illustrates a side cross-sectional side view of an eye includingan example of a prosthetic capsular device and an IOL;

FIG. 32 illustrates an anterior plan view of the example prostheticcapsular device of FIG. 31;

FIG. 33 illustrates a side perspective view of the example prostheticcapsular device of FIG. 31;

FIG. 34 illustrates an anterior plan view of another example of aprosthetic capsular device;

FIG. 35 illustrates an anterior plan view of yet another example of aprosthetic capsular device;

FIG. 36 illustrates an exploded side perspective view of still anotherexample of a prosthetic capsular device;

FIG. 37A illustrates an exploded anterior plan view of yet still anotherexample of a prosthetic capsular device;

FIG. 37B illustrates an exploded side perspective view of the exampleprosthetic capsular device of FIG. 37A;

FIG. 38A illustrates an exploded anterior plan view of another exampleof a prosthetic capsular device;

FIG. 38B illustrates an exploded side perspective view of the exampleprosthetic capsular device of FIG. 38A;

FIG. 39 illustrates a side cross-sectional side view of an eye includingan example of a prosthetic device;

FIG. 40 illustrates a side cross-sectional side view of an eye includinganother example of a prosthetic device and an IOL;

FIG. 41 illustrates a side cross-sectional side view of an eye includingyet another example of a prosthetic device and an IOL;

FIG. 42 illustrates a side cross-sectional side view of an eye includingstill another example of a prosthetic device;

FIG. 43A illustrates an anterior side perspective view of an example ofa prosthetic capsular device;

FIG. 43B illustrates an anterior plan view of the example prostheticcapsular device of FIG. 43A;

FIG. 43C illustrates a cross-sectional view of the example prostheticcapsular device of FIG. 43A along the line 43C-43C of FIG. 43B;

FIG. 43D illustrates a cross-sectional view of the example prostheticcapsular device of FIG. 43A along the line 43D-43D of FIG. 43B;

FIG. 43E illustrates an anterior side perspective view of an example ofa prosthetic capsular device system;

FIG. 43F illustrates an anterior plan view of the example prostheticcapsular device system of FIG. 43E;

FIG. 43G illustrates a cross-sectional view of the example prostheticcapsular device system of FIG. 43E along the line 43G-43G of FIG. 43F;

FIG. 43H illustrates a side view of the example prosthetic capsulardevice system of FIG. 43E;

FIGS. 44A and 44B are photographs of animal study results annotated tohighlight certain features;

FIGS. 45A-45E are photographs of animal study results for a right eye ofa first rabbit;

FIGS. 46A-46E are photographs of animal study results for a left eye ofthe first rabbit;

FIGS. 47A-47E are photographs of animal study results for a right eye ofa second rabbit;

FIGS. 48A-48E are photographs of animal study results for a left eye ofthe second rabbit;

FIGS. 49A-49E are photographs of animal study results for a right eye ofa third rabbit;

FIGS. 50A-50E are photographs of animal study results for a left eye ofthe third rabbit;

FIGS. 51A-51E are photographs of animal study results for a right eye ofa fourth rabbit;

FIGS. 52A-52E are photographs of animal study results for a left eye ofthe fourth rabbit;

FIGS. 53A-53E are photographs of animal study results for a right eye ofa fifth rabbit;

FIGS. 54A-54E are photographs of animal study results for a left eye ofthe fifth rabbit;

FIG. 55A is a flowchart of an example of controlling focus of an IOLusing an external device;

FIG. 55B is a schematic of a system for controlling an electronic deviceusing an external device;

FIG. 55C is a flowchart of an example of controlling an electronicdevice using an external device;

FIG. 55D is a flowchart of another example of controlling an electronicdevice using an external device;

FIG. 55E is a flowchart of another example of controlling an electronicdevice using an external device;

FIG. 55F is a flowchart of another example of controlling an electronicdevice using an external device;

FIG. 56 is a block diagram depicting an example computer hardware systemconfigured to execute software for implementing one or more embodimentsof electronic device control disclosed herein;

FIG. 57A is an exploded perspective view of an example kit including aprosthetic capsular device;

FIG. 57B is a top plan view of the example kit of FIG. 57A;

FIG. 57C illustrates a cross-sectional view of the example kit of FIG.57A along the line 57C-57C of FIG. 57B;

FIG. 57D illustrates a cross-sectional view of the example kit of FIG.57A along the line 57D-57D of FIG. 57B;

FIG. 57E illustrates a cross-sectional view of the example kit of FIG.57A along the line 57E-57E of FIG. 57B;

FIG. 57F is a top plan view of a component of the example kit of FIG.57A;

FIG. 58A illustrates an anterior side perspective view of an example ofa prosthetic capsular device;

FIG. 58B illustrates an anterior plan view of the example prostheticcapsular device of FIG. 58A;

FIG. 58C illustrates a cross-sectional view of the example prostheticcapsular device of FIG. 58A along the line 58C-58C of FIG. 58B;

FIG. 58D illustrates a cross-sectional view of the example prostheticcapsular device of FIG. 58A along the line 58D-58D of FIG. 58B;

FIG. 58E illustrates an anterior plan view of an example prostheticcapsular device;

FIG. 58F illustrates an anterior plan view of the example prostheticcapsular device;

FIG. 58G illustrates an anterior plan view of an example prostheticcapsular device system;

FIGS. 58H-58L illustrate anterior plan views of example prostheticcapsular devices;

FIG. 59A illustrates a side view of an example prosthetic capsulardevice;

FIGS. 59B and 59C illustrate an example method of use of the exampleprosthetic capsular device of FIG. 59A

FIGS. 60A-60N illustrate an example method of loading and ejecting theexample prosthetic capsular device of FIG. 58E;

FIG. 61A illustrates an anterior side perspective view of an exampleprosthetic capsular device;

FIG. 61B illustrates an anterior plan view of the example prostheticcapsular device of FIG. 61A;

FIG. 61C illustrates a side view of the example prosthetic capsulardevice of FIG. 61A;

FIG. 61D illustrates a side view of an example prosthetic capsulardevice;

FIG. 62A illustrates an anterior side perspective view of an exampleprosthetic capsular device;

FIG. 62B illustrates an anterior plan view of the example prostheticcapsular device of FIG. 62A;

FIG. 62C illustrates a side view of the example prosthetic capsulardevice of FIG. 62A;

FIG. 63A illustrates an anterior side perspective view of an exampleprosthetic capsular device;

FIG. 63B illustrates an anterior plan view of the example prostheticcapsular device of FIG. 63A;

FIG. 63C illustrates a side view of the example prosthetic capsulardevice of FIG. 63A;

FIG. 64A illustrates an anterior side perspective view of an exampleprosthetic capsular device;

FIG. 64B illustrates an anterior plan view of the example prostheticcapsular device of FIG. 64A;

FIG. 64C illustrates a side view of the example prosthetic capsulardevice of FIG. 64A;

FIG. 65A illustrates an anterior side perspective view of an exampleprosthetic capsular device;

FIG. 65B illustrates an anterior plan view of the example prostheticcapsular device of FIG. 65A;

FIG. 65C illustrates a side view of the example prosthetic capsulardevice of FIG. 65A;

FIG. 66A illustrates an anterior side perspective view of an exampleprosthetic capsular device;

FIG. 66B illustrates an anterior plan view of the example prostheticcapsular device of FIG. 66A;

FIG. 66C illustrates a side view of the example prosthetic capsulardevice of FIG. 66A;

FIG. 67A illustrates an anterior side perspective view of an exampleprosthetic capsular device;

FIG. 67B illustrates an anterior plan view of the example prostheticcapsular device of FIG. 67A;

FIG. 67C illustrates a side view of the example prosthetic capsulardevice of FIG. 67A;

FIG. 68A illustrates an anterior side perspective view of an exampleprosthetic capsular device;

FIG. 68B illustrates an anterior plan view of the example prostheticcapsular device of FIG. 68A;

FIG. 68C illustrates a side view of the example prosthetic capsulardevice of FIG. 68A;

FIG. 68D illustrates a side view of an example prosthetic capsulardevice system including the example prosthetic capsular device of FIG.68A;

FIG. 69A illustrates an anterior side perspective view of an exampleprosthetic capsular device;

FIG. 69B illustrates an anterior plan view of the example prostheticcapsular device of FIG. 69A;

FIG. 69C illustrates a side view of the example prosthetic capsulardevice of FIG. 69A;

FIG. 69D illustrates a side view of an example prosthetic capsulardevice system including the example prosthetic capsular device of FIG.69A;

FIG. 70A illustrates an anterior side perspective view of an exampleprosthetic capsular device;

FIG. 70B illustrates an anterior plan view of the example prostheticcapsular device of FIG. 70A;

FIG. 70C illustrates a side view of the example prosthetic capsulardevice of FIG. 70A;

FIG. 71A illustrates a perspective view of an example device forcoupling to a prosthetic capsular device;

FIG. 71B illustrates an example coupling of the example device of FIG.71A with an example portion of a prosthetic capsular device;

FIG. 71C illustrates an example coupling of an example device with anexample portion of a prosthetic capsular device;

FIG. 71D illustrates an example coupling of an example device with anexample portion of a prosthetic capsular device;

FIG. 72A illustrates an anterior side perspective view of an exampleprosthetic capsular device;

FIG. 72B illustrates a magnified side view of an example portion of theexample prosthetic capsular device of FIG. 71B;

FIG. 73A illustrates an anterior side perspective view of an exampleprosthetic capsular device in an unfolded state;

FIG. 73B illustrates an anterior plan view of the example prostheticcapsular device of FIG. 73A in an unfolded state;

FIG. 73C illustrates a side view of the example prosthetic capsulardevice of FIG. 73A in an unfolded state;

FIG. 73D illustrates an anterior plan view of the example prostheticcapsular device of FIG. 73A in a folded state;

FIG. 73E illustrates an anterior side perspective view of the exampleprosthetic capsular device of FIG. 73A in a folded state;

FIG. 74A illustrates an anterior side perspective view of an exampleintraocular lens;

FIG. 74B illustrates an anterior side perspective view of an exampleprosthetic capsular device containing the intraocular lens of FIG. 74A;

FIG. 74C illustrates an anterior side perspective view of an exampleprosthetic capsular device containing an example intraocular lens;

FIG. 74D illustrates an anterior side perspective view of an exampleprosthetic capsular device containing an example intraocular lens;

FIG. 74E illustrates an anterior side perspective view of an exampleprosthetic capsular device containing an example intraocular lens;

FIG. 75A illustrates an anterior plan view of an example prostheticcapsular device system;

FIG. 75B illustrates an anterior plan view of an example medicamentdelivery device of the prosthetic capsular device system of FIG. 75A;

FIG. 75C illustrates an anterior plan view of another example medicamentdelivery device of a prosthetic capsular device system;

FIG. 75D illustrates an anterior side perspective view of anotherexample medicament delivery device of a prosthetic capsular devicesystem;

FIG. 75E illustrates an anterior side perspective view of an exampleprosthetic capsular device system including the medicament deliverydevice of FIG. 75D;

FIG. 76A illustrates an anterior plan view of an example prostheticcapsular device;

FIG. 76B illustrates an anterior plan view of an example prostheticcapsular device;

FIG. 76C illustrates an anterior plan view of an example prostheticcapsular device;

FIG. 76D illustrates an anterior plan view of an example prostheticcapsular device;

FIG. 76E illustrates an anterior plan view of an example prostheticcapsular device;

FIG. 76F illustrates an anterior plan view of an example prostheticcapsular device;

FIG. 77A illustrates an anterior plan view of an example prosthetic irisdevice;

FIG. 77B illustrates a posterior plan view of the example prostheticiris device of FIG. 77A;

FIG. 77C illustrates a plan view of the example prosthetic iris deviceof FIG. 77A coupled to an example prosthetic capsular device disclosedherein;

FIG. 77D illustrates a plan view of an example prosthetic iris devicecoupled to an example prosthetic capsular device disclosed herein;

FIG. 77E illustrates an anterior plan view of an example prosthetic irisdevice;

FIG. 77F illustrates a posterior plan view of the example prostheticiris device of FIG. 77E;

FIG. 77G illustrates an anterior plan view of an example prosthetic irisdevice;

FIG. 77H illustrates a posterior plan view of the example prostheticiris device of FIG. 77G;

FIG. 77I illustrates a plan view of the example prosthetic iris deviceof FIG. 77G coupled to an example prosthetic capsular device disclosedherein;

FIG. 78A is an anterior side perspective view of an example prostheticcapsular device;

FIG. 78B is an anterior plan view of the example prosthetic capsulardevice of FIG. 78A;

FIG. 78C is a cross-sectional view of the example prosthetic capsulardevice of FIG. 78A along the line 78C-78C of FIG. 78B;

FIG. 78D is an anterior plan view of another example prosthetic capsulardevice;

FIG. 78E is an anterior plan view of yet another prosthetic capsulardevice;

FIG. 78F is an anterior plan view of still another prosthetic capsulardevice;

FIG. 79A is a top perspective view of an example embodiment of a ringstructure portion;

FIG. 79B is a left side view of the ring structure portion of FIG. 79A;

FIG. 79C is a right side view of the ring structure portion of FIG. 79A;

FIG. 79D is an upper end view of the ring structure portion of FIG. 79A;

FIG. 79E is a lower end view of the ring structure portion of FIG. 79A;

FIG. 79F is a top plan view of the ring structure portion of FIG. 79A,the bottom plan view being a mirror image;

FIG. 80A is a top perspective view of an example embodiment of a ringstructure portion;

FIG. 80B is a left side view of the ring structure portion of FIG. 80A;

FIG. 80C is a right side view of the ring structure portion of FIG. 80A;

FIG. 80D is an upper end view of the ring structure portion of FIG. 80A;

FIG. 80E is a lower end view of the ring structure portion of FIG. 80A;and

FIG. 80F is a top plan view of the ring structure portion of FIG. 80A,the bottom plan view being a mirror image.

The patent or application file contains at least one drawing executed incolor. Copies of this patent or patent application publication withcolor drawing(s) will be provided by the Office upon request and paymentof the necessary fee.

DETAILED DESCRIPTION

Some prosthetic capsular enclosure devices (e.g., prosthetic capsularbags) that can be used in the eye can hold at least one of a technologydevice (e.g., an electronic technology device (e.g., a wearableelectronic technology device (e.g., a miniaturized wearable electronictechnology device))) and an intraocular lens.

Examples of preferred prosthetic capsular devices that may be compatiblewith certain implementations described herein are disclosed in PCTPublished Patent Application No. WO 2013/126380, which is incorporatedherein by reference in its entirety. Some preferred prosthetic capsulardevices are described herein.

With reference to FIGS. 1-3, a prosthetic capsular device or PPL-C 10 isshown approximating the size, shape, and volume of a natural human lens.The dimensions of the prosthetic capsular device 10 may be variable, sothat physicians may order an implant that most closely matches the lensof the eye 12 being operated on. The human lens varies in thickness fromabout 3.5 millimeters (mm) to about 5.5 mm. A natural lens tends to bethicker in more hyperopic eyes and thinner in more myopic eyes. Anatural lens thickens over time, and increased age is associated with athicker lens on average. The diameter of the human lens is about 9 mm.In some implementations, the prosthetic capsular device 10 comprises asubstantially discoid (e.g., a substantially flat, substantiallycircular disc) and/or spheroid (e.g., prolate spheroid, oblate spheroid)shape having a thickness between about 1.5 mm and about 5.5 mm (e.g.,about 2.5 mm) and a diameter between about 8.5 mm and about 10 mm (e.g.,about 9 mm). For purposes of clarity, the thickness of the prostheticcapsular device 10 is the distance between the anterior surface 14 andposterior surface 16 of the prosthetic capsular device 10 along thevisual axis 15 (FIG. 2), for example in contrast with the thickness ofwalls of the device 10. The anterior surface 14 includes an arcuate(e.g., circular, oval) opening 18 having a diameter between about 5 mmand about 7 mm (e.g., about 6 mm), and has an exterior contour, such as,for example, a flange 20 (e.g., having a thickness between about 0.5 mmand about 1.5 mm (e.g., about 1 mm), substantially surrounding (e.g.,surrounding) and extending radially outwardly from the opening 18. Theflange 20 can assist in stabilization and/or centration of theprosthetic capsular device 10 by extending into and fitting in theciliary sulcus 22 (FIG. 1). The flange 20 may lack or be substantiallyfree of perforations, which may increase stability and appositionsurface area of the flange 20. The prosthetic capsular device 10 may bedimensioned to fit precisely in a capsulorhexis created by a femtosecondlaser.

At least a portion of the inner face or side 17 of the posterior surfaceor portion 16 of the prosthetic capsular device 10 may comprise arefractive surface, which may, for example, allow a pseudophakicrefraction to be performed intraoperatively with a known lens alreadyinside the eye 12, e.g., the posterior refractive surface 19. In theimplementation shown in FIGS. 1-3, substantially the entire inner face17 comprises a low power refractive surface (e.g., about +1 diopter(D)). While the posterior refractive surface 19 is generally discussedherein in terms of a +1 D surface, the posterior refractive surface 19may comprise any and all lens powers and designs that are currentlyknown in the art of intraocular lenses, including, but not limited to:spherical, aspheric, wavefront, convex, concave, multifocal(diffractive, refractive, zonal), toric, accommodative, ultraviolet (UV)filtering, diffractive chromatic aberration reducing lenses, lightadjustable lenses (ultraviolet light adjustable, femtosecond phasewrapping), and optical powers ranging from any positive diopter value(e.g., including +35 D and above) to any negative diopter value (e.g.,including −35 D and below).

The posterior refractive surface 19 may advantageously reduce therefractive power of the IOL to be placed in the device 10. For example,if the device did not include a posterior surface (e.g., comprised asimple or modified ring), then one or more IOL devices would provide allof the refractive power, which could increase the volume of the IOL,leading to a larger incision and associated complications. A posteriorrefractive surface implanted in the eye can advantageously allow for asecond refractive device to be coupled with (e.g., placed within, nextto, and/or on top of) the posterior refractive surface. The posteriorrefractive surface 19 can allow the ELP of the eye to be determinedalong with any residual refractive error. If any further refractiveerror is discovered, a second refractive device can be added to theposterior refractive surface 19 (e.g., immediately), which canneutralize the deficit and help ensure that the desired outcome isachieved. The posterior refractive surface 19 being integrally formedwith the remainder of the device 10, which can be accurately placed andanchored, can inhibit or prevent shifting of lateral and/orposterior-anterior position, rotation, tilt, etc. of the posteriorrefractive surface 19 that could lead to degradation of vision. Thecontinuous nature of the device 10 on all sides except for the anterioropening 18 can inhibit, reduce, or prevent ingrowth of lens epithelialcells, and thereby can inhibit or prevent formation of intra-lenticularopacifications.

The device 10 comprising a refractive surface 19, rather than being athrough hole of an annulus, for example, can reduce the volume of an IOLinserted therein, which may advantageously reduce incision size. Theposterior refractive surface 19 may provide protection for the naturalcapsular bag 24 during placement of an IOL. For example, the IOL isinhibited or prevented from directly contacting the natural capsular bag24 because the IOL instead contacts the device 10. For another example,vitreous is inhibited or prevented from contacting the IOL. Sidewalls ofthe device 10 that do not include apertures large enough for a portion(e.g., a haptic) of an IOL to prolapse through may provide protectionfor the natural capsular bag 24 during placement of an IOL, for examplebecause the IOL is inhibited or prevented from directly contacting thenatural capsular bag 24.

The prosthetic capsular device 10 is adapted to be implanted in the eye12. The prosthetic capsular device 10 preferably comprises abiologically-compatible material that would be inserted inside the eye12. The prosthetic capsular device 10 is preferably deformable so as tobe folded and inserted via an injection system through a cornealincision ranging between about 0.1 mm and about 10 mm, preferablybetween about 1.5 mm and about 3 mm. The size of the corneal incisionvaries based on several factors, including, for example, the volume ofthe prosthetic capsular device 10, the plasticity of the prostheticcapsular device 10, the volume of the injection cartridge through whichthe prosthetic capsular device 10 will be delivered, frictional forces,combinations thereof, and the like. The capsulorhexis is preferablybetween about 4 mm and about 7 mm (e.g., about 6 mm), although, if afemtosecond laser is used, the capsulorhexis should be less than thedilated diameter of the patient's pupil, as a femtosecond lasergenerally cannot create a capsulotomy through the iris. A capsulorhexiscreated manually may be about the same size as a capsulorhexis createdby a femtosecond laser, as direct visualization of the rhexis boundaryis advisable throughout the creation process. The capsulorhexis rangesbetween about 3 mm and about 8 mm, preferably between about 4 mm andabout 7 mm. During implantation, the folded prosthetic capsular device10 passes through the corneal incision, through the capsulorhexis, andinto the patient's natural capsular bag 24 (FIG. 1). The naturalcapsular bag 24 may be fully, partially, or not intact, or is missing ora remnant, although it is preferred to place the device 10 in an intactnatural capsular bag 24 other than the continuous curvilinearcapsulorhexis, devoid of natural lens material, with intact zonules. Ifthe natural capsular bag 24 is not sufficiently intact, alternativetechniques may be employed, for example to secure the device 10 to theposterior chamber (e.g., suturing the device 10 to the scleral wall).The prosthetic capsular device 10 preferably possesses sufficientelasticity to resume its pre-folded shape, for example byself-expanding, once positioned inside the eye 12. Intraocular lensescomprising materials including silicone, polyimide, collamer, andacrylic can have one or more of these capabilities. In someimplementations, the prosthetic capsular device 10 comprises abiologically-compatible, optically clear material similar or identicalto those used in foldable intraocular lenses.

The prosthetic capsular device 10 is preferably inserted in the naturalcapsular bag 24 of the eye 12 of a patient through the use of aninjection system. The injection system can allow the prosthetic capsulardevice 10 to be folded or automatically folded into a smaller shape asthe prosthetic capsular device 10 is advanced through the injectionsystem so as to allow the prosthetic capsular device 10 to fit throughan incision much smaller than the diameter of the unfolded prostheticcapsular device 10. Injection systems through which IOLs are injectedinto the eye, for example comprising a cylindrical cartridge and anadvancement rod on a screw type advancement system or plungeradvancement system, would be suitable for use with the prostheticcapsular device 10. Other injection systems are also possible.

The prosthetic capsular device 10 is preferably inserted in a naturalcapsular bag 24 of the eye 12 of a patient who has had cataract surgerywith the use of a laser (e.g., a femtosecond laser) to create acapsulorhexis, although insertion into natural capsular bag 24 aftermanual creation of the capsulorhexis is also possible. A femtosecondlaser may be used to create the capsulorhexis, for example after thesame femtosecond laser or a different femtosecond laser or a differentdevice was used to make the other incisions including the main wound,the paracentesis, and any corneal or limbal relaxing incisions. Thepatient's natural lens, for example clouded by a cataract such that itmay be itself termed a “cataract,” may be removed using techniques knownin the art. For example, the natural lens material may be broken up andvacuumed out, leaving the natural capsular bag 24 partially, fully, ornot intact, or being missing or a remnant. The residual cortex may beremoved using techniques known in the art such as viairrigation/aspiration. An aphakic refraction may be completed using anintraocular refracting device such as, for example, the ORA System,available from Alcon Surgical, Ft. Worth, Tex. (formerly WaveTec ofAliso Viejo, Calif., or the Holos IntraOp system available from ClarityMedical Systems, Inc. of Pleasanton, Calif.1. An IOL calculation may beperformed using an algorithm such as, for example, the Mackoolalgorithm. The patient's natural capsular bag 24 and anterior segment 26may be inflated with a viscoelastic material, such as sodium hyaluronate(e.g., Provisc, Healon, Viscoat). The prosthetic capsular device 10 maybe loaded into an injection device, for example by being folded into asmall tubular shape, and injected into the natural capsular bag 24. Theviscoelastic material may be removed from behind the prosthetic capsulardevice 10 and from the anterior segment 26. A pseudophakic refractionmay be performed with a system similar to a standard auto-refractor orthe intraoperative refracting system. This calculation is preferablyperformed using approved protocols. An intraoperative Optical CoherenceTomography system, such as the Zeiss OMPI Lumera 700 with ReScan 700,could be used to measure the exact position of the prosthetic capsulardevice 10 in the eye 12, relative to the cornea and the retina. Alongwith pre-operative measurements of the cornea and axial length, theposition of prosthetic capsular device 10 as determined by the OCTmeasurement could allow the surgeon to determine the power of a lensthat would provide the desired refraction using a vergence formula.

An example refraction using an approved protocol, and accompanyingbackground information, is discussed herein. Current state of the artrequires multiple independent variables to be measured so that thedependent variable of effective lens position can be estimated. Theseven independent variables in the Holladay 2 formula (one of the mostpopular modern formulas) are, in decreasing order of importance: (1)axial length, (2) average keratometric power, (3) horizontal white towhite, (4) refraction, (5) anterior segment depth, (6) lens thickness,and (7) age. These variables are then used to estimate the EffectiveLens Position. However, this position is simply an estimation orprediction. If the estimation or prediction of the positon is incorrect,the post-operative refractive outcome will be compromised. Therefore,emphasis should be placed on the ability to determine the ELP ratherthan estimating the ELP. The prosthetic capsular device 10 can helpdetermine the ELP in one, two, or more different ways, as describedherein.

FIG. 4A is a flow chart of an example method for inserting andpositioning a prosthetic capsular device 10 into a patient's eye 12,with continued reference to FIGS. 1-3. First, the lens thickness of apatient's natural lens is determined preoperatively using knowntechniques. Next, a prosthetic capsular device 10 having a thicknesssimilar to the thickness of the patient's natural lens is selected.Selection of a prosthetic capsular device 10 sized such that the innerface 17 of the prosthetic capsular device 10 is at the same location asthe posterior surface of the patient's natural lens is preferred suchthat, when an IOL 28 is inserted in the prosthetic capsular device 10,that IOL 28 will be positioned in substantially the identical locationpreviously occupied by the patient's natural lens. Although the naturalcapsular bag 24 remains open, a combination of very thin lenses may beused such that lenses may be positioned slightly differently than thenatural lens as measured from cornea to lens surface or back surface toretina. The prosthetic lens of ideal power can be appropriatelyidentified and inserted in the eye 12 to provide the desired refractiveendpoint.

A femtosecond laser and/or manual keratome may be used to form the mainwound, the paracentesis, any corneal or limbal relaxing incisions. Thefemtosecond laser and/or manual technique may be used to create thecapsulorhexis. The patient's natural lens or cataract is then removedusing techniques known in the art. The residual cortex is removed usingtechniques known in the art, such as via irrigation/aspiration. Then,the patient's natural capsular bag 24 and anterior segment 26 are filledwith viscoelastic material, and the prosthetic capsular device 10 isinserted into the natural capsular bag 24. The viscoelastic material isthen removed from behind the prosthetic capsular device 10 and from theanterior segment 26 in preparation for performing a pseudophakicrefraction.

By being able to identify and control the position of the IOL 28,choosing an IOL 28 may be independent of the seven variables used forELP in the Holladay 2 formula. Rather, via theoretical vergenceformulas, the exact IOL 28 that can provide a desired refractive outcomecan be specifically calculated using keratometric power, effective lensposition, and axial length. The weakness of the formulas currently usedis the inability to accurately estimate or predict ELP. To confirm thatthe pre-operative theoretical calculation is correct, a refraction maybe performed in the operating room once the prosthetic capsular device10 is implanted in the patient's eye via an intraoperative refractingsystem, retinoscopy, or by other known methods. The refraction willtechnically be a pseudophakic refraction, as the posterior refractivesurface 19 of the prosthetic capsular device 10 has a refractive power,such as, for example, +1 diopter.

A method to determine the correct intraocular power for a piggyback lensmay be calculated by first determining the power of the IOL 28 to beimplanted using Equation 1:

$\begin{matrix}{{IOLe} = {\frac{1336}{\frac{1336}{\frac{1000}{\frac{1000}{PreRx} - V} + {Ko}} - {ELPo}} - \frac{1336}{\frac{1336}{\frac{1000}{\frac{1000}{DPostRx} - V} + {Ko}} - {ELPo}}}} & \left( {{Eq}.\mspace{14mu} 1} \right)\end{matrix}$wherein: IOLe=IOL power; ELPo=effective lens position; Ko=net cornealpower; V=vertex distance; PreRx=pre-oprefraction (also can represent theintra-operative refraction after the prosthetic capsular device has beenplaced); and DPostRx=desired post-operative refraction.

The Effective Lens Position (ELP or ELPo) is the distance from thesecondary principal plane of the cornea to the principal plane of thethin-IOL equivalent. The keratometric power of the cornea (Kk) can beconverted to the net optical power of the cornea (Ko) using Equation 2:Ko=Kk×0.98765431  (Eq. 2)For example, if the Kk is 44.50 D, Ko=44.50 D×0.98765431=43.95 D. Thenet optical power of the cornea would then be 43.95 D.

By comparing the pre-operative theoretical IOL calculations with theaphakic refraction, the prosthetic capsular device refraction, and thepost-IOL implantation refraction, surgeons can greatly improve theaccuracy of their post-operative refractive outcomes.

Still referring to FIG. 4A, once the appropriate IOL 28 is selected, theprosthetic capsular device 10 and anterior segment 26 are refilled withviscoelastic material and, based on the residual refractive error, theappropriate IOL 28 is selected and inserted into the prosthetic capsulardevice 10. The viscoelastic material is then removed from the eye 12,and the wounds are closed through standard methods such as hydration,suturing, etc. A final confirmatory refraction may be completed whileensuring normal intraocular pressure, which can affect the position ofthe prosthetic capsular device 10 and IOL 28 inside the eye 12. Ifsignificant error was found at this point, the surgeon may remove theimplanted IOL and replace the implanted IOL with a more desirable IOL(e.g., having a more desirable refractive power), substantially withoutrisking damage to the fragile natural capsular bag 24, due to theprotective nature of having the IOL 28 contained in the prostheticcapsular device 10. The ability provided by the natural capsular device10 to remove and insert IOLs is described further herein.

The device 10 may be used as a stand-alone intraocular lens for theprimary correction of aphakia. A device 10 including a particular lensmay be chosen based on pre-operative measurements and/or theoreticalformulae. Intraoperative aberommetry could also be used in the aphakicmode to help aid in the selection of the device 10 including its lens orposterior refractive surface 19. While this technique and implementationdoes not necessarily take advantage of the improvement of ELP predictionand identification, use the device 10 as a stand alone intraocular lens,with the ability to contain other technology of various types forimplantation in the future, is a reasonable solution.

The following method or surgical procedure for implanting a prostheticcapsular device as described herein has been successfully used in animalstudies using three New Zealand white rabbits of same sex and weighingbetween 2.4 kg and 3.2 kg and in animal studies using five New Zealandwhite rabbits of same sex and weighing between 3.2 kg and 3.6 kg. Theanimals were quarantined for at least seven days and grossly checked forthe presence of any anomalies prior to the beginning of the procedure.Each animal was prepared for surgery by pupil dilation with 1%cyclopentolate hydrochloride and 2.5% phenylephrine drops, appliedtopically three times each spaced by a duration of five minutes.Anesthesia was obtained with an intramuscular injection of ketaminehydrochloride (50 mg/kg) and xylazine (7 mg/Kg) in a mixture of 7:1,respectively. One drop of topical proparacaine hydrochloride anestheticwas also placed in each eye prior to beginning surgery. Eye movement andanimal respiration were monitored intraoperatively to ensure thatadequate levels of anesthesia were maintained. Supplemental anestheticswere given intramuscularly as needed during the operation. The areaaround the eye was draped in an aseptic manner. A lid speculum wasplaced to retract the lids. One drop of povidone-iodine (PVP-I) 5% and adrop of antibiotic was placed on the surface of the eye just beforebeginning surgery. Using aseptic technique and a Zeiss surgicalmicroscope, a fornix-based conjunctival flap was fashioned. Acorneal-scleral incision was made using a crescent blade, and an initial3.0 mm limbal incision was made using a 3.0 mm keratome to enter theanterior chamber. Capsulorhexis forceps were used to create a wellcentered continuous curvilinear capsulotomy (CCC), with a diameterbetween about 5.0 mm and about 5.5 mm.

After hydrodissection, a phacoemulsification handpiece (Alcon Infinitisystem) was inserted into the posterior chamber for removal of lensnucleus and cortical material. One milliliter (mL) of epinephrine 1:1000and 0.5 mL of heparin (10,000 USP units/mL) were added to each 500 mL ofirrigation solution to facilitate pupil dilation and controlinflammation. The endocapsular technique was used with thephacoemulsification to take place entirely within the natural capsularbag. The residual cortex was then removed with the anirrigation/aspiration (I/A) handpiece. After removal of the naturallens, an ophthalmic viscosurgical device (OVD) (Amvisc Plus, Bausch &Lomb) was used to inflate the natural capsular bag.

As shown in FIGS. 4B-4D, the prosthetic capsular device was theninjected by using an appropriate injector system (“A” cartridge andMonarch II injector from Alcon Laboratories; Accuject 2.2-1P injectorset from Medicel), after the surgeon slightly increased the incisionsize. Loading of the prosthetic capsular device into the injectors wasfound to be uneventful. If the prosthetic capsular device was injectedpartially out of the natural capsular bag (e.g., due to fibrinformation, papillary restriction, injector limitation, etc.), theprosthetic capsular device was able to be manipulated with a collarbutton hook to complete in-the-bag fixation. Careful control of theinjector may inhibit or prevent rapid or uncontrolled release of theprosthetic capsular device from the injector. Even when the plunger ofan injector overrode the prosthetic capsular device inside the plunger,injection in the natural capsular bag was possible.

As shown in FIGS. 4E-4G, this was followed by insertion of IOLs (AcrySofSN60AT, a single-piece hydrophobic acrylic IOL manufactured by Alcon)using the Monarch II injector and “C” cartridges. The AcrySof lens wasfully fixated within the prosthetic capsular device in all instances,uneventfully. The device and IOL were carefully inspected under highmagnification for any possible damage that might have occurred duringthe loading/implantation process. Centration of the prosthetic capsulardevice and of the IOL inside of the prosthetic capsular device was foundto be excellent in all cases. In three eyes, the natural capsular bagcontaining the prosthetic capsular device and the AcrySof lens wasslightly oval.

Combination antibiotics/steroid ointment (neomycin and polymyxin Bsulfates, and dexamethasone) was applied to the eyes following surgery.The same ointment was placed in the eyes four times per day for thefirst postoperative week. Ointment was discontinued after one week. Inthe second postoperative week, each animal received topical prednisoloneacetate drops four times per day. In the third postoperative week, eachanimal received topical prednisolone acetate drops two times per day,with discontinuation of the drops following the third postoperativeweek.

The eyes were evaluated grossly at day one, and by slit lamp examinationwith scoring for ocular inflammatory response at one, two, three, andfour weeks postoperatively (±2 days) and photographs were taken (seebelow). At each of these examinations, the rabbit eyes were dilatedusing a combination of cyclopentolate hydrochloride solution andphenylephrine. A standard scoring method in eleven specific categorieswas used at each examination, including assessment of corneal edema, aswell as the presence of cell and flare within the anterior chamber.Retro-illumination images with the pupil fully dilated were obtained forthe purpose of photographic documentation regarding CCC size, anteriorcapsule opacification (ACO), posterior capsule opacification (PCO), andany observed capsular fibrosis at the discretion of the study directors.The images are provided and discussed in further detail herein.

After the clinical examination at four weeks, the animals wereanesthetized using a 1 to 2 cm³ (cc) intramuscular injection of a 7:1mixture of ketamine hydrochloride and xylazine, and then humanelyeuthanized with a 1 mL intravenous injection of pentobarbitalsodium/phenytoin sodium. The globes were enucleated and placed in 10%neutral buffered formalin. The globes were then bisected coronally justanterior to the equator. Gross examination and photographs from theposterior aspect (Miyake-Apple view) were performed to assess the ACOand PCO development, as well as IOL fixation. The extent and severity ofACO and PCO were scored according to established methods.

After gross examination and photographs, all globes were sectioned andthe anterior segments including the capsular bags were processed forstandard light microscopy and stained with hematoxylin and eosin (H &E). Features such as cell type, extent and route of growth, etc. weredocumented by serial photomicrographs.

FIGS. 4H-4J illustrate another example prosthetic capsular device 400,in which FIG. 4H is a side view, FIG. 4I is an anterior plan view, andFIG. 4J is a cross-sectional view of along the line 4J-4J of FIG. 4I.The device 400 is illustrative of the prosthetic capsular devices usedin the animal studies described herein, with certain modifications whereindicated.

The device 400 comprises a posterior side 402 and an anterior side 404.The posterior side 402 has a diameter 408 between about 5 mm and about10 mm (e.g., about 9.5 mm). The anterior side 404 has a diameter 410between about 5 mm and about 10 mm (e.g., about 9 mm). The diameter 410of the anterior side 404 may be between about 0.25 mm and about 1 mm(e.g., about 0.5 mm) less than the diameter 408 of the posterior side.The device 400 comprises a generally cylindrical portion having thediameter 408 from the posterior side 402 to the flange 406, a taperedportion tapering from the diameter 408 to the diameter 410 anterior tothe flange 406, and another generally cylindrical portion having thediameter 410 from the tapered portion to the anterior side 404. Thetapered portion may be straight, arcuate, and/or combinations thereof.

The posterior side 402 has a generally flat end shape and a roundedrefractive portion 414 inwardly set back from the end of the posteriorside 402, as best seen in FIG. 4J. The refractive portion 414 provides arefractive property to the device 400. The refractive portion 414 has adiameter 424 between about 4 mm and about 9 mm (e.g., about 5.9 mm). Theillustrated refractive portion 414 has a refractive power of 5 D with aradius of curvature 426 of about 19.32 mm) although other refractivepowers (e.g., 0 D, <0 D, >0 D, ±35 D, etc.) and radii of curvature(e.g., at least partially depending on one or more of refractive power,the diameter 424, material, etc.) are also possible.

The anterior side 404 comprises an opening 410, which allows theinsertion of an IOL as discussed herein. The opening 410 may have adiameter 418 between about 5 mm and about 10 mm (e.g., about 9 mm). Thesidewalls of the device 400 optionally do not extend radially inwardlysuch that the opening 410 may have a large or maximum diameter (e.g.,based on the diameter of the inner surface of the sidewalls of thedevice 400). A larger opening 410 may aid insertion of the IOL and/orreduce volume and/or mass, which can aid insertion into small incisions(e.g., by being easier to compress into and/or advance through aninjection device). A smaller opening 410 may aid in containment of anIOL (e.g., better defining the interior volume of the device 400 and/orinhibiting anterior drift on an inserted IOL). The anterior side 404and/or the posterior side 402 may comprise a lip or ridge 432 on aradial exterior.

The distance 430 between the flange 406 and the refractive portion 414may be between about 0.5 mm and about 2 mm (e.g., about 1 mm). Thedistance 420 between the anterior end 404 and the refractive portion 414may be between about 1 mm and about 5 mm (e.g., about 2.5 mm). Asdescribed herein, in devices comprising a flange, the flange may beanywhere along the longitudinal axis of the device.

The device 400 comprises sidewalls between the posterior end 402 and theanterior end 404. The sidewalls may have a radial thickness 422 betweenabout 0.1 mm and about 0.5 mm (e.g., about 0.26 mm). The sidewallsoptionally extend posterior to the refractive portion 414 and/oranterior to or substantially longitudinally even with the opening 412.The sidewalls may extend towards the anterior side 404 and/or theposterior side 402 to form a lip or ridge 432.

The device 400 illustrated in FIGS. 4H-4J includes a flange or ring 406having an anterior-posterior thickness 428 of about 0.3 mm and a radialthickness ((diameter 416—diameter 408)/2) of about 0.25 mm, but theflange 406 was removed from the devices used in the animal studies suchthat the outer diameter of the devices was the diameter 408. If theflange 406 is not removed, other thicknesses are also possible. Forexample, a flange 406 having thicker dimensions may be less prone totearing upon loading in a delivery syringe and/or insertion in an eye.

The prosthetic capsular device 10 can enhance the ability to achievedesired refractive targets, with a side benefit of increased safety. Theprosthetic capsular devices (e.g., the prosthetic capsular device 10and/or variants thereof) described herein can provide one or more ofthese advantages in one or more of several ways. Although variousnumbered potential advantages are listed, each advantage may includesub-advantages or alternative advantages, and not all devices 10 need toaccomplish every enumerator or otherwise described potential advantage.

First, with reference again the FIGS. 1-3, the prosthetic capsulardevice 10 can provide centration of the IOL 28 along the visual axis 15.A femtosecond cataract laser system has the ability to center thecapsulorhexis around the visual axis 15 of the patient rather than theoptical center of the cataract. The capsulorhexis is ultimately whatwill center the prosthetic capsular device 10 as the capsulorhexis isthe opening through which the prosthetic capsular device 10 will beinserted. The capsulorhexis is juxtaposed at the center of theprosthetic capsular device 10, centering the prosthetic capsular device10. The prosthetic capsular device 10 may optionally be stabilized viathe flange 20 extending into and fitting in the ciliary sulcus 22. Theflange 20 can mechanically retain the prosthetic capsular device 10centered on the patient's visual axis 15 and inhibit or prevent futuremovement or migration of the prosthetic capsular device 10, althoughcentering and inhibited movement are also possible without a flange 20.

Centration of the IOL 28 on the visual axis 15 can be important to thevisual function of the IOL 28 and the benefit the patient receives.Aspheric lenses have made decentration more tolerable, however improvedcentration can be advantageous to the increase or optimize visualperformance of multifocal intraocular lenses. Decentration by less than1 mm can cause significant morbidity, so much so that surgicalintervention including laser pupiloplasty, IOL repositioning, and IOLexchange are often performed. The prosthetic capsular device 10 iscentered along the visual axis 15 via the capsulorhexis. An IOL 28commonly includes haptics 30 which can engage opposed interior surfacesin the prosthetic capsular device 10 to maintain the centered positionof the IOL 28. The outer diameter of the IOL 28, when unfolded andincluding the haptics 30, may be substantially equal to or less than theinner diameter of the prosthetic capsular device 10. The IOL 28 can becentered by being in physical contact with the peripheral internalsurface of the prosthetic capsular device 10 that is centered in thevisual axis 15, which maintains the centered position of the IOL 28 inthe prosthetic capsular device 10 and also in the visual axis 15.

Second, the prosthetic capsular device 10 can provide a prostheticbarrier between the anterior segment 26 and posterior segment 32 of theeye 12 in the case of inadvertent rupture of the posterior surface ofthe natural capsular bag 24, or after planned neodymium-doped yttriumaluminum garnet (Nd:YAG) laser posterior capsulotomy. Despite theoverall success of cataract surgery, there is still about 2% surgicalcomplication rate utilizing modern techniques, although this variesamong individual surgeons. Residents in ophthalmology training programshave historically had complication rates around 4-7%. Most complicationsfrom cataract surgery are caused by inadvertent rupture of the naturalcapsular bag 24, which houses the cataract. The natural capsular bag 24also provides an important anatomical barrier within the eye 12 bydividing the anterior segment 26 from the posterior segment 32. Theposterior segment 32 contains the vitreous body, retina, optic nerve,and the central retinal artery and vein. A violation of the integrity ofthe barrier provided by the natural capsular bag 24 allows fluidcommunication between the anterior segment 26 and the posterior segments32, and potentially the ocular surface. Vitreous may flow out of theposterior segment 32 according to pressure gradients, flowing from highpressure (e.g., in the posterior segment 32) toward low pressure (e.g.,the anterior segment 26). A pressure gradient can cause vitreous to flowdirectly to the surgical incision site in the lower pressure anteriorsegment 26. Vitreous can inhibit or prevent wound healing if present atthe surgical incision site, and more significantly can provide a conduitfor microbial infections to proceed directly to the posterior segment32. In addition to the problems caused by vitreous, a break or tear inthe natural capsular bag 24 can inhibit or prevent the stableimplantation of an IOL 28 in the posterior segment 32. Surgeons canplace an IOL 28 in the ciliary sulcus 22 or the anterior chamber,although each of these alternatives has their own potentialcomplications associated with them. The natural capsular bag 24 isdesirably maintained intact, as there are currently no methods toconsistently reestablish the integrity of the natural capsular bag 24once it has been compromised. Should the natural capsular bag 24 becompromised, the prosthetic capsular device 10 may serve as a prostheticbarrier between the anterior segment 26 and posterior segment 32.

About 30% of all implanted intraocular lenses develop visuallysignificant posterior capsular opacification. If this develops, a Nd:YAGlaser may be used to create an opening in the posterior surface of thenatural capsular bag 24 to remove this opaque membrane. If the IOL 28 isto be removed after a Nd:YAG laser posterior capsulotomy has beenperformed, the chances for serious complications rise dramaticallybecause the barrier between the vitreous and the anterior segment 26 hasbeen lost due to the Nd:YAG-created opening in the posterior surface ofthe natural capsular bag 24. If a prosthetic capsular device 10 isplaced in the natural capsular bag 24 and Nd:YAG laser posteriorcapsulotomy has been performed, the prosthetic capsular device 10 canprovide an adequate barrier for the vitreous, inhibiting or preventingvitreous from flowing out of the posterior segment 32. The haptics 30,which hold the IOL 28 in place inside the prosthetic capsular device 10,are not prone to scar formation or fibrosis because they contact theprosthetic capsular device 10 rather than the natural capsular bag 24,which can make future lens removal easier and decrease the risk forcomplications during IOL 28 exchange. The prosthetic capsular device 10can provide a platform for routine IOL 28 exchange, as described furtherherein.

Third, the prosthetic capsular device 10 can limit chronic capsularopacification that takes place in the natural capsular bag 24 and thatcan cause refractive shifts due to ELP change, anterior capsularphimosis, and visually significant posterior capsular opacification.After cataract surgery has been performed, the natural capsular bag 24undergoes chronic changes. These changes are largely due to the presenceof lens epithelial cells that remain on the natural capsular bag 24after surgery. These epithelial cells continue to grow and can causeproblems. For example, the anterior surface of the natural capsular bag24 can fibrose and contract over time, causing a progressively smalleraperture overtop of the lens. If the entire natural capsular bag 24becomes fibrotic, and phimosis persists, there can be zonular dehiscenceand changes to the effective lens position over time. About 30% of thetime, the posterior surface of the natural capsular bag 24 becomessignificantly opacified, which may be remedied by a Nd:YAG laserposterior capsulotomy. The effect of limiting epithelial cell migrationand propagation can be mediated by the type of material that theprosthetic capsular device 10 comprises (e.g., hydrophobic acrylicmaterials, which tend to be most efficacious of all currently known andused IOL materials).

Fourth, the prosthetic capsular device 10 can help maintain theeffective lens position of an IOL 28 implanted into the eye 12.Precisely matching the preoperative dimensions of the cataract with theprosthetic capsular device 10 can enhance the ability to predict the ELPof the lens implant 28. Currently, the ELP of an IOL 28 is estimated orpredicted based on a number of factors, including the depth of theanterior segment 26, lens thickness, and white to white diameter, amongothers. The accuracy of the prediction is actually quite low, resultingin only 50% of patients being within a tolerable level of theirrefractive goal post-cataract surgery. While other dimensions of the eyerequired for standard IOL calculation can be measured quite preciselyand accurately, the ELP has remained the elusive last great variable toconquer in the quest for highly accurate and predictable IOLcalculations for cataract surgery.

The reason for the great variability in the ELP is due to the volumetricdifference between the cataract and the IOL 28. The average thickness ofthe human cataract at age 65 is approximately 4.5 mm, but varies frompatient to patient. In contrast, an IOL 28 is typically less than 1 mmthick and/or produces no or substantially no anterior-posterior (Z-axis)stabilization inside the natural capsular bag. The thickness of the IOLgenerally does not match the thickness of the cataract due todeliverability issues, as thicker IOLs generally use a larger incision.The resulting volumetric difference allows for pressure differentialsbetween the posterior segment 32 and the anterior segment 26, as well ascontraction of the natural capsular bag 24, which can shift the finalresting position of the IOL 28. The lens thickness may be measuredpreoperatively and a prosthetic capsular device 10 with a correspondingvolume and thickness may be implanted. By implanting a prostheticcapsular device 10, the volume of the natural capsular bag 24 mayeffectively be held constant and/or in accordance with the cataract. Thenatural capsular bag 24, buttressed by the prosthetic capsular device10, can resist forces that would otherwise shift the natural capsularbag 24 and its contents anteriorly or posteriorly. This stability oflens capsule volume and/or Z-axis stabilization of the lens inside theprosthetic capsular bag and the natural capsular bag can increase orsignificantly increase the accuracy of IOL calculations.

Fifth, the prosthetic capsular device 10 can allow for an intraoperativepseudophakic refraction while still allowing another IOL to be implantedwithout explanting an originally implanted lens. Recently, there havebeen advances in IOL calculation methodologies that use intraoperativerefraction devices, such as the WaveTec ORA System, the WaveTec OrangeSystem, the HOLOS IntraOp from Clarity Medical Systems, Inc., etc., toprovide better refractive outcomes. These devices can perform aphakicrefractions, pseudophakic refractions, and assist with the alignment oftoric IOLs 28 and assist with Limbal Relaxing Incisions. Aphakicrefractions do not have the benefit of a lens inside the eye, so ELP isstill a variable for which this data cannot account. Pseudophakicrefractions can be helpful, but provide the information only after theIOL 28 has been implanted. If the data shows that a different IOL 28would be more beneficial, the physician would explant the lessbeneficial IOL 28 and implant a more beneficial IOL 28. Explanting anIOL 28 takes time, effort, and skill, and can cause damage to thenatural capsular bag 24, zonules, cornea, and/or other structures withinthe eye 12. Using a prosthetic capsular device 10 with a low power lensincorporated into its posterior surface (e.g., the posterior refractivesurface 19) can allow a physician to perform a pseudophakic refractionwith this refractive surface, and still provides the physician theability to implant a second lens (e.g., the IOL 28) within theprosthetic capsular device 10 that will make up the refractivedifference as measured by an intraoperative refraction device, such asthe WaveTec ORA System and Clarity HOLOS.

Stabilization of the natural capsular bag 24 by insertion of theprosthetic capsular device 10 can be leveraged to perform anintraoperative optical coherence tomography (OCT) measurement and/or Aor B scan ultrasound, for example using commercially available systemssuch as the Zeiss RESIGHT OCT and/or any of a multitude of ophthalmicA/B scan ultrasound systems. Once the prosthetic capsular device 10 isinserted into the natural capsular bag 24, the anterior and posteriorcapsule can be stented open into a stable configuration, which should beunlikely to significantly change post operatively. By knowing thecorneal power, the distance from the cornea to the refractive surface ofthe prosthetic capsular device 10, and the distance from the refractivesurface of the prosthetic capsular device 10 to the surface of theretina, the ELP can be determined. By knowing the ELP, the power of thecornea, the refractive power built in to the posterior aspect of theprosthetic capsular device 10, and the axial length of the eye 12 (e.g.,from the surface of the corneal epithelium to the internal limitingmembrane (ILM) (ultrasonic technique), the retinal pigment epithelial(RPE) layer (laser interferometry technique), from cornea to retina), anappropriate second lens (e.g., of an IOL) can be selected and implantedinto the open space in the prosthetic capsular device 10 to provide thedesired refractive outcome.

Sixth, the prosthetic capsular device 10 may serve as a means forpharmaceutical delivery. Pharmaceuticals, drugs, and medications, suchas, for example, slow release fully or partially dissolvable medicinepellets, non-dissolvable prostheses coated with slow releasepharmaceutical agents, and/or other substances intended for introductioninto the eye 12 may be placed in and/or on prosthetic capsular device 10outside of the visual axis 15 in a location that is not subject tosequestration by membrane formation. There is a tremendous amount ofresearch and demand for a slow release implant that would essentiallyeliminate the need for post-cataract surgery eye drops. The prostheticcapsular device 10 would be a suitable receptacle for such an implant,as the periphery of the interior of the prosthetic capsular device 10provides a location outside of the visual axis 15, in constant contactwith the aqueous humor, substantially without risk of becomingencapsulated by scarring. Due to the prosthetic material of theprosthetic capsular device 10, there would be little to no risk ofmembrane formation or encapsulation. Dissolved or suspendedpharmaceuticals would not affect the patient's vision and could beintroduced directly into the prosthetic capsular device 10 during theimplantation surgery. Larger pharmaceuticals, such as slow releasemedicine pellets, may be shaped to mechanically maintain their positionwith respect to the prosthetic capsular device 10. For example, a slowrelease medicine pellet may be constructed with a generally toroidalshape sized to fit within the prosthetic capsular device 10, whileremaining in the peripheral space and not obstructing the visual axis15. Alternatively, slow release pharmaceutical agents may be placedinside a carrier that is mechanically configured to fit inside theprosthetic capsular device in order to ensure the agent remains in placeand/or do not migrate into the visual axis and/or outside of theprosthetic device even after substantial dissolution.

Seventh, the prosthetic capsular device 10 may provide physicians withthe ability to perform a lens exchange in the future that can reduce orminimize the risk of damage to the natural capsular bag 24 and zonularapparatus, which ultimately can substantially reduce or minimize therisk of serious vision threatening sequlae such as macular edema,macular hole, retinal tear, retinal detachment, proliferativevitreoretinopathy, and/or loss of capsular support leading to lessfavorable lens implantation techniques (e.g., a sutured or glued IOL 28,an anterior chamber IOL 28, a posterior chamber IOL 28, etc.). As statedabove, if a prosthetic capsular device 10 is placed in the naturalcapsular bag 24 and a Nd:YAG laser posterior capsulotomy has beenperformed, the prosthetic capsular device 10 provides an adequatebarrier for the vitreous. The haptics 30 which hold the IOL 28 in placeinside the prosthetic capsular device 10 are not prone to scarformation, making future removal and/or exchange of the IOL 28 easier.

FIGS. 5-7 depict another example prosthetic capsular device 110. Theprosthetic capsular device 110 is a substantially discoid shape having athickness between about 2.5 mm and about 4.5 mm and a diameter of about9 mm, although other dimensions, for example as described herein withrespect to the prosthetic capsular device 10, 400, are also possible.The thickness of the prosthetic capsular device 110 is the distancebetween the anterior surface 114 and posterior surface 116 of theprosthetic capsular device 110 along the visual axis 15. The anteriorsurface 114 contains a circular opening 118 having a diameter of about 6mm. At least a portion of the inner face 117 of the posterior surface116 of the prosthetic capsular device 110 comprises a refractivesurface, e.g., the posterior refractive surface 119. The prostheticcapsular device 110 lacks or is free of a flange 20 (as in theprosthetic capsular device 10) that could mechanically fixate or centerthe prosthetic capsular device 110 on the capsulorhexis. The volume ofthe prosthetic capsular device 110 relative to the opening of thecapsulorhexis may keep the device in place similar to the manner inwhich current single piece IOLs 28 are folded and placed within thenatural capsular bag 24.

The prosthetic capsular device 110 may sacrifice a measure of stabilityas compared to the prosthetic capsular device 10 comprising a flange 20.Without a flange, the prosthetic capsular device 110 may be usable fornon-femtosecond laser cataract removal (e.g., traditional manualphacoemulsification), and may be particularly useful for surgeons wholack access to a femtosecond laser.

The lenticular surface on the posterior aspect of a prosthetic capsulardevice may have a plano powered lens. Some extreme myopes would notbenefit from a +1 D refractive surface, as they may benefit from anegative IOL 28 power. For patients with these conditions, a prostheticcapsular device may be used with a plano or zero power posteriorlenticular surface.

The prosthetic capsular device may have a negative posterior refractivelenticular surface (e.g., −1 D, −2 D, −3 D, −4 D, −5 D, −6 D, −7 D, −8D, −9 D, −10 D, or more), as some extreme axial myopes (about 30 mm andbeyond) may benefit from this type of lens.

The posterior refractive surface of a prosthetic capsular device maycomprise a multifocal lenticular surface, which could aid in presbyopiacorrection. This multifocal lenticular surface may include, but is notlimited to, refractive, diffractive, and zonal multifocal refractivetechnology. A multifocal lens may be designed to provide multiple focalpoints generally ranging from plano (e.g., 0 D) to +3 D or greater atthe spectacle plane.

The posterior refractive surface of a prosthetic capsular device mayinclude a spherical, aspheric, and/or cylindrical (astigmatic)lenticular surface so as to aid in the correction of pre-existing andsurgically induced corneal astigmatism. As most surgeons induce between−0.25 D and −0.50 D of astigmatism with their corneal incisions requiredfor cataract surgery, it would be beneficial even for most patients withspherical corneas to have this neutralized. The diopteric power of thetoric correction could increase up to 6 diopters for patients with evenhigher amounts of astigmatism.

In some implementations described herein (e.g., the prosthetic capsulardevice 110 shown in FIG. 6, the prosthetic capsular device 400 with theflange 406 removed or never formed), the prosthetic capsular device(e.g., bag, bowl, housing, structure, cage, frame) does not include oris free of a flange. Certain such implementations may include, around aperimeter of the prosthetic capsular device 210, an outer rim comprisingtabs or haptics 205. The rim may be continuous, and tabs 205 that are incontact may be considered continuous. Tabs 205 that are continuous mayprovide better apposition with the natural capsular bag and/or be moreform fitting than a device in which the tabs 205 are not continuous. Thetabs 205 may position (e.g., center) the device 210 in a desiredposition. Some or all of the tabs 205 may include an opening or hole220, for example in the approximate center of the tab 205. An exampleprosthetic capsular device 210 comprising a continuous outer rimcomprising tabs 205 each including an opening or hole 220 is illustratedin FIG. 8. The rim, tabs 205, and/or openings 220 can assist theprosthetic capsular device 210 to fit inside natural capsular bags ofmany sizes and shapes. The prosthetic capsular device 210 preferablyallows for some fibrosis through the openings 220, which can stabilizethe capsule 210 in the event of a Nd:YAG laser posterior capsulotomy.The tabs 205 can comprise, for example, silicone, silicone derivatives,acrylic, acrylic derivatives, biocompatible methacrylates (e.g.,poly(methyl methacrylate) (PMMA)), collamer, olefins (e.g.,polypropylene), polyimide, combinations thereof, and the like. The tabs205 may comprise the same material as (e.g., be integrally formed with)the remainder of the device 210 or may comprise a different materialthan the remainder of the device 210 (e.g., being overmolded over theremainder of the device 210). The device 210, like other prostheticcapsular devices described herein, may comprise a plurality of piecesand/or materials, which may advantageously allow selection or use of amaterial suitable for the function of that component, as opposed toselection or use of a material having compromising suitability forseveral functions. If the remainder of the device 210 comprises opaquematerial, the tabs 205 may comprise opaque and/or transparent material,for example because the opaque material of the remainder of the device210 can reduce or minimize intraocular scattering and/or glare such thatlight may not reach the tabs 205. The prosthetic capsular device 210 caninclude an internal lip 230. The internal lip 230 can run partially,intermittently, or completely around the inside of the prostheticcapsular device 210. The lip 230 may be designed to hold the haptics ofan IOL stable, inhibiting or preventing the lens from rotating orshimmering during eye movements.

In some implementations, the prosthetic capsular device intentionallymoves away from natural form fitting conformation of the posterioraspect of the device. This can allow for the posterior aspect of theprosthetic capsular device to have a larger diameter (e.g., the largestdiameter possible for the physiology), potentially allowing for implantswith a wider diameter to be implanted, and to have a more stabilizingeffect on the lens that the device will be holding.

In some implementations, the prosthetic capsular device 210 comprises atleast one of the following: external form-fitting elements (e.g., thetabs 205 shown in FIG. 8); openings in the external form-fittingelements through which fibrosis can take place, thereby allowingstabilization of the positioning of the device (e.g., the openings 220in the tabs 205 shown in FIG. 8); and an internal lip/sulcus configuredto secure the haptics of a standard IOL (e.g., the lip 230 shown in FIG.8).

FIGS. 9A-9D illustrate another example prosthetic capsular device 900,in which FIG. 9A is a side view, FIG. 9B is a side cross-sectional view,FIG. 9C is a posterior plan view, and FIG. 9D is an anterior sideperspective view. The prosthetic capsular device (e.g., bag, bowl,housing, structure, cage, frame) 900 does not include or is free of aflange, although combination with a flange (e.g., the flange 20) is alsopossible. The device 900 comprises a posterior side 902 and an anteriorside 904. The posterior side 902 has a generally rounded shape. As shownin FIG. 9B, the posterior side 902 comprises a refractive portion, whichprovides a refractive property to the device 900.

As shown in FIGS. 9B and 9D, the anterior side 904 comprises an opening910, which allows the insertion of an IOL as discussed herein. Theopening 910 may have sharp edges (e.g., as depicted in FIGS. 9B and 9D),rounded edges (e.g., as shown in other implementations herein), etc.Sharp edges may reduce material volume and allow insertion of the device900 through a smaller incision. The opening 910 may have a diameterbetween about 5 mm and about 10 mm (e.g., between about 6 mm and about 9mm). The sidewalls of the device 900 optionally do not extend radiallyinwardly such that the opening 910 may have a large or maximum diameter(e.g., based on the diameter of the inner surface of the sidewalls ofthe device 900). A larger opening 910 may aid insertion of the IOLand/or reduce volume and/or mass, which can aid insertion into smallincisions (e.g., by being easier to compress into and/or advance throughan injection device). A smaller opening 910 may aid in containment of anIOL (e.g., better defining the interior volume of the device 900 and/orinhibiting anterior drift on an inserted IOL).

As shown in FIGS. 9B and 9D, the device 900 comprises an internal lip912. The internal lip 912 can run partially, intermittently, orcompletely around the inside of the prosthetic capsular device 900. Thelip 912 may be designed to hold the haptics of an IOL stable, inhibitingor preventing the lens from rotating or shimmering during eye movements.The lip 912 is proximate to a midpoint of the device 900, for examplebeing proximate to a plane about half way between the posterior side 902and the anterior side 904. The lip 912 may be proximate to the anteriorside 902, proximate to the anterior side 904, etc., and can be designedand/or selected based on the IOL to be inserted into the device 900. Thedevice 900 may comprise a plurality of lips 912, for example configuredto engage a plurality of IOLs and/or to provide a plurality ofalternative positions to engage one IOL. The lip 912 may comprise atubular structure, for example configured to lockingly engage haptics ofan IOL (e.g., by insertion of end portions of one or more haptics into alumen of the tubular structure, by resilient compression of the tubularstructure by a haptic, etc.). Rather than extending radially inwardly(e.g., as shown in FIGS. 9B and 9D), the lip 912 could extend radiallyoutwardly, for example comprising a groove in the inner sidewalls of thedevice 900. A lip 912 comprising a groove may be integrally formed(e.g., during molding of the device 900) and/or formed after (e.g., bylaser milling or diamond lathe cutting). Combinations of the lips 912described herein are also possible. For example, the lip 912 couldcomprise: one or a plurality of lips 912; position(s) proximate to asurface and/or a midpoint; continuous and/or intermittent; filled and/ortubular; a groove extending into the sidewalls of the device 900; andcombinations thereof.

The device 900 comprises, around a perimeter of the device 900, aplurality of tabs or haptics 906. The tabs 906 are not in contact andmay be considered not continuous. Tabs 906 that are not continuous mayuse less material and impart less volume and/or mass to the device 900,allowing the device 900 to be easier to insert into small incisions. Useof less material may reduce costs due to use of less material. Asdiscussed above, tabs that are continuous may provide better appositionwith the natural capsular bag and/or be more form fitting, but may usemore material and impart more volume and/or mass to a device, which caninhibit insertion into small openings. Depending on the application, thedevices described herein that include tabs may include tabs that arecontinuous, not continuous, and combinations thereof (e.g., comprisingcontinuous tabs over a portion of the perimeter).

The tabs 906 comprise an opening or hole or aperture 908. The openings908 illustrated in FIGS. 9A-9D extend all of the way through the tabs906, but could extend only partially through the tabs 906. The openings908 may assist in suturing the device 908, allow fibrosis therethrough,etc. The tabs 906 include tabs 906 a that are anteriorly biased and tabs906 b that are posteriorly biased. Biased tabs 906 (e.g., tabs 906 a,906 b having alternating bias) can inhibit preferential torqueing andtilt. In addition and/or alternatively to being differently biased, thetabs 906 may have other differences (e.g., shape, material, absence ofan opening 908, anterior-posterior position, orientation, combinationsthereof, and the like).

FIGS. 10A-10D illustrate yet another example prosthetic capsular device1000, in which FIG. 10A is a side view, FIG. 10B is a sidecross-sectional view, FIG. 10C is a posterior plan view, and FIG. 10D isan anterior side perspective view. The prosthetic capsular device (e.g.,bag, bowl, housing, structure, cage, frame) 1000 does not include or isfree of a flange, although combination with a flange (e.g., the flange20) is also possible. The device 1000 comprises a posterior side 1002and an anterior side 1004. The posterior side 1002 has a generally flatshape. As shown in FIG. 10B, the posterior side 1002 comprises a solidsurface, but substantially constant thickness and parallel planarsurfaces are indicative of a lack of a refractive portion, which may beuseful if the IOL provides sufficient refractive power (e.g., if thediopter value is low). Although the posterior side 1002 is flat, theinterior surface of the posterior part of the device 1000 could becurved such that the device 1000 can provide refractive power eventhough the outer surface is flat.

As shown in FIGS. 10B and 10D, the anterior side 1004 comprises anopening 1010, which allows the insertion of an IOL as discussed herein.The opening 1010 may have sharp edges (e.g., as shown in otherimplementations herein), rounded edges (e.g., as depicted in FIGS. 10Band 10D), etc. Curved surfaces are more likely to transmit light thansharp surfaces, so an opening 1010 comprising rounded edges may reducerefraction of light and inhibit or prevent unwanted reflections ordysphotopsias.

As shown in FIGS. 10B and 10D, the device 1000 comprises an internal lip1012. The internal lip 1012 can comprise the same options and/orfeatures as discussed herein (e.g., with respect to the lip 912). Thelip 1012 is proximate to the posterior side 1002, for example beingposterior to a plane half way between the posterior side 1002 and theanterior side 1004 and/or being posterior to the tabs 1006. Consistentwith the lip 1012 comprising the options of other lips described herein,the lip 1012 may be proximate to the anterior side 1004, proximate to amidpoint, etc., and can be based on the IOL to be inserted into thedevice 1000.

The device 1000 comprises, around a perimeter of the device 1000, afirst plurality of tabs or haptics 1006 and a second plurality of tabsor haptics 1007. The tabs 1006, 1007 can comprise the same optionsand/or features as discussed herein (e.g., with respect to the tabs906). The pluralities of tabs 1006, 1007 are not in contact and may beconsidered not continuous. The pluralities of tabs 1006, 1007 are spacedfrom each other about a perimeter of the device 1000, bunched at twoopposite sides of the device 1000. Pluralities of tabs may be bunched atone side, two sides (e.g., as shown in FIGS. 10A-10D), three sides, etc.Pluralities of tabs may be evenly circumferentially spaced (e.g., asshown in FIGS. 10A-10D) or unevenly circumferentially spaced.Pluralities of tabs may comprise the same types of tabs (e.g., as shownin FIGS. 10A-10D) or different types of tabs (e.g., comprising differentanterior-posterior bias, shape, material, absence of an opening 1008,anterior-posterior position, orientation, continuousness, combinationsthereof, and the like). Tabs within a plurality of tabs may be the sameor different (e.g., comprising different anterior-posterior bias (e.g.,as shown by the tabs 1006 a, 1006 b in the plurality of tabs 1006),shape, material, absence of an opening 1008, anterior-posteriorposition, orientation, continuousness, combinations thereof, and thelike). In implementations in which the tabs comprise circumferentiallyspaced pluralities of tabs (e.g., the tabs 1006, 1007), the tabs may beconfigured to provide more engagement (e.g., by being larger, by beingcontinuous, combinations thereof, and the like) than if the tabs extendall around the perimeter of the device. Use of fewer tabs bycircumferentially spacing pluralities of tabs 1006, 1007 may reducevolume and/or mass, which can aid insertion into small incisions (e.g.,by being easier to compress into and/or advance through an injectiondevice). Use of fewer tabs by circumferentially spacing pluralities oftabs 1006, 1007 may reduce costs due to use of less material. Asdiscussed above, tabs that are continuous may provide better appositionwith the natural capsular bag and/or be more form fitting, but haveincreased volume and/or mass. Depending on the application, the devicesdescribed herein that include tabs may include tabs that are continuous,not continuous, and combinations thereof (e.g., comprising continuoustabs over a portion of the perimeter).

The tabs 1006, 1007 are illustrated as being generally short,rounded-edge rectangular structures. Other shapes are also possible, forexample arcuate (e.g., semicircular), elongate (e.g., spiraling out ofthe device 1000), having end features (e.g., loops, hooks), etc. Whenpluralities of tabs 1006, 1007 are circumferentially spaced, theperimeter of the device 1000 may have room for more voluminous tabs1006, 1007.

As shown in FIGS. 10A, 10C, and 10D, the device 1000 comprises texturedsurfaces 1014. The textured surfaces 1014 may comprise pores (e.g.,extending partially through the walls of the device, extending fullythrough the walls of the device 1000, circular, spherical, elongate,having an undulating pattern, etc.), surface texture patterns,combinations thereof, and the like. The textured surfaces 1014 may beconfigured to capture, engage, and/or promote fibrosis (e.g., by notbeing smooth). The textured surfaces 1014 may be formed during formingthe device 1000 (e.g., by being integrated into a mold) and/or formedafter forming the device 1000 (e.g., by laser drilling). The device 1000and/or other prosthetic capsular devices may lack or be free of tabs1006, 1007, and the textured surfaces 1014 may provide engagement withthe natural capsular bag, allow fibrosis, etc. The device 1000 maycomprise tabs 1006, 1007 comprising openings or holes 1008 that mayassist in suturing the device 908, allow fibrosis therethrough, etc. andtextured surfaces 1014 that may allow fibrosis. The textured surfaces1014 of the device 1000 are positioned between the pluralities of tabs1006, 1007, but any portion of the device 1000 may comprise a texturedsurface, preferably not in the optical path, which can permit strategicfibrosis. The textured surfaces 1014 may be continuous around theperimeter, circumferentially spaced (e.g., as shown in FIG. 10C), inpatches, etc. If the device 1000 comprises tabs, the tabs may comprisetextured surfaces.

FIGS. 11A-11C and 11E illustrate still another example prostheticcapsular device 1100, in which FIG. 11A is a side view, FIG. 11B is aside cross-sectional view, FIG. 11C is a posterior plan view, and FIG.11E is an anterior side perspective view. FIG. 11D depicts a posteriorplan view of still yet another example prosthetic capsular device 1150that is similar to the device 1100 except for the refractive portion, asdescribed in further detail below. The prosthetic capsular device (e.g.,bag, bowl, housing, structure, cage, frame) 1100 does not include or isfree of a flange, although combination with a flange (e.g., the flange20) is also possible. The device 1100 comprises a posterior side 1102and an anterior side 1104.

The posterior side 1102 has a generally flat edge with a convex centralportion. As shown in FIG. 11C, convex central portion of the posteriorside 1102 comprises a refractive portion, which provides a refractiveproperty to the device 1100 for refractive powers>0 D (positive orconverging lens power). The posterior side 1102 can include a concavecentral portion for refractive powers<0 D (negative or diverging lenspower). As shown in FIG. 11C, the refractive portion of the device 1100has a diameter 1116 that is about 6 mm. As shown in FIG. 11C, therefractive portion of a similar device 1150 has a diameter 1166 that isabout 8 mm. Most IOL optics have a diameter between 5.5 mm and 6 mmsince the refractive power range of IOLs is typically ±35 D, and IOLsare designed to be substantially the same throughout the refractivepower range such that even low refractive power IOLs have a diametersimilar to that of a high refractive power IOL. The diameters of therefractive portion of the devices 1100, 1150 are not limited byrefractive power value, which can allow larger diameter refractiveportions as evidenced by the device 1150. The devices 1100, 1150 couldprovide a small refractive power value to aid an IOL, which could allowIOLs with smaller refractive powers to be used, resulting in a totalrefractive power, which could potentially increase the diameter of suchIOLs if no longer designed based on a full refractive power range. Thedevices 1100, 1150 could provide a refractive surface that hassufficient refractive power that no IOL providing additional refractivepower is inserted into device 1100, 1150.

As shown in FIGS. 11B and 11D, the anterior side 1104 comprises anopening 1110, which allows the insertion of an IOL as discussed herein.The opening 1110 may have sharp edges (e.g., as shown in otherimplementations herein), rounded edges (e.g., as depicted in FIGS. 11Band 11E), etc. Sharp edges may reduce material volume and allowinsertion of the device through a smaller incision. Curved surfaces aremore likely to transmit light than sharp surfaces, so an openingcomprising rounded edges may reduce refraction of light and inhibit orprevent unwanted reflections or dysphotopsias.

As shown in FIGS. 11B and 11E, the device 1100 lacks or is free of aninternal lip. Lack of an internal lip may reduce volume and/or mass,which can aid insertion into small incisions (e.g., by being easier tocompress into and/or advance through an injection device). Lack of aninternal lip may reduce costs due to use of less material.Alternatively, the device 1100 may comprise an internal lip, as thefeatures described with respect to the devices described in the presentapplication may be optionally substituted, interchanged, rearranged,etc. when compatible.

The device 1100 comprises, around a perimeter of the device 1100, aplurality of tabs or haptics 1106. The device 1150 comprises, around aperimeter of the device 1150, a plurality of tabs or haptics 1156. Thetabs 1106, 1156 can comprise the same options and/or features asdiscussed herein (e.g., with respect to the tabs 906, 1006, 1007). Thepluralities of tabs 1106, 1156 are not in contact and may be considerednot continuous. The tabs 1106, 1156 are not biased in an anterior and/orposterior direction, which may be easier to manufacture than biasedtabs. The tabs 1106, 1156 are larger than the tabs 906, 1006, 1007described herein. Larger tabs 1106, 1156 may increase apposition of thedevice 1100, 1150 to a natural capsular bag and/or increase fibrosissurface area. Larger tabs 1106, 1156 may also allow the formation oflarger openings 1108, 1158. Openings that extend all the way through atab, if desired, may be difficult to produce in small tabs, so thelarger tabs 1106, 1156 may enable easier formation of larger openings1108, 1158 that fully extend through the tabs 1106, 1156. Largeropenings 1108, 1158 may aid in suturing.

The prosthetic capsular devices described herein or similar prostheticcapsular devices may be compatible with any IOLs that are currentlycommercially available or developed in the future, regardless ofmanufacturer (e.g., AcrySof platform of lenses from Alcon, TECNIS ZCB00,ZKB00, ZLB00, ZMB00, ZCT, and Symfony extended depth of focus lensesfrom Abbott Medical Optics, enVista, TRULIGN, Akreos, SofPort, andCrysalens from Bausch and Lomb, iSert from Hoya Corporation, ELENZASapphire from Elenza, Calhoun light adjustable lens from Calhoun Vision,and others), material (e.g., comprising PMMA, silicone, relativelyhydrophobic acrylic, relatively hydrophilic acrylic, other acrylic,collamer, combinations thereof, and the like), product type (e.g.,aphakic, pseudophakic), refractive power (e.g., negative, planar, andpositive), number of pieces (e.g., one, two, three, and more),accommodation (e.g., accommodating and non-accommodating), size (e.g.,diameter, thickness), shape (e.g., disc, toroid, symmetric, andasymmetric), haptic type and quantity, delivery system, deliveryprofile, expansion profile, combinations thereof, and the like.

Referring again to the potential advantages described above, theprosthetic capsular devices described herein or similar prostheticcapsular devices can increase the options for IOL replacement. Aphysician may be less reluctant to perform IOL replacement if theinitially-implanted lens fails due to the reduce risk of complications,such that the physician will more readily replace theinitially-implanted lens with a more appropriate lens, thereby providinga better outcome (e.g., initial outcome). Even without replacement, theIOL selection capability provided by the refractive portion of theprosthetic capsular device and/or the positioning capability provided bythe prosthetic capsular device and can improve outcome (e.g., initialoutcome). Certain prosthetic capsular devices described herein may beable to provide more accurate refractive outcomes after initial surgeryevery or almost every time.

Since IOL replacement from a prosthetic capsular device involves lessrisk than IOL replacement without a prosthetic capsular device,physicians and patients may also be more open to replacement of the IOLover time. For example, IOL replacement may be potentially advantageousfor medical reasons (e.g., due to changing physiological conditions(e.g., development of macular degeneration, glaucomatous opticneuropathy), refractive reasons (e.g., change of corneal power due tocorneal dystrophy, the progressive hyperopic shift associated withprevious refractive keratotomy), the patient's desire to access newintraocular technology (e.g., powered accommodating IOL, implantableintraocular wireless input/output computerized devices)), such thatreplacement of an IOL in a prosthetic capsular device can provideimproved outcomes even after the initial surgery. The reduced risk ofcomplications due to removal from and placement in a prosthetic capsulardevice may even permit physicians and patients to exchange the IOL asoften as desirable. The ability to change the IOL more often due to aprosthetic capsular device may also permit surgery at an earlier age, asthe physician may dispossess concerns that the initially-implanted IOLmust last the rest of the patient's life or risk serious complicationsupon replacement. Such IOL replacement procedures may even be able tosubstitute for removable corrective devices such as glasses and contactlenses.

The prosthetic capsular devices described herein or similar prostheticcapsular devices may provide a platform by which a technology device(e.g., a wearable miniaturized electronic technology device) can beinserted and carried in the eye independent of or in combination with anIOL. As used herein, the phrase “technology device” is a broad termincluding any device that generally provides biometric measurementfunctions, computer functions (e.g., digital data input directly viawireless signals and/or indirectly through sensors, data analysis,input, and/or output), image generation and projection onto the retina,and/or internet/WiFi capabilities and is small enough to fitfunctionally within the eye (e.g., having a diameter less than or equalto about 11 mm and a thickness less than or equal to about 6 mm), someof which can be used to perform useful electronic functions for thewearer. Examples of such devices include, but are not limited to,computers (e.g., Google Glass, Microsoft Hololens), virtual realitydevices, augmented reality devices, head-mounted displays (such asgraphic or image displays, map displays), devices with WiFi and/orinternet connectivity, image receivers (e.g., television or movies),game devices, projectors (including image viewers, image readers, orimage senders), GPS devices, biometric measurement devices (e.g.,aqueous humor glucose and electrolyte sensor, Intraocular VEGF sensor,blood glucose level sensors, electrolyte sensors, heart rate sensors,basal metabolic rate sensors, temperature sensors, EEG, EKG, intraocularpressure sensors, ciliary muscle contraction sensors, dynamic pupilchange sensors), retinal prostheses, camera functions (e.g., still imageand/or video recording), and e-mail senders or receivers. Such devicesdo not necessarily have to be characterizeable as wearable (e.g.,because they are implanted rather than “worn”), miniaturized (e.g.,because they may have already been a certain size), or electronic (e.g.,because they may be mechanical), but would still be a “technologydevice” as described herein.

In use, the technology device is in the prosthetic capsular device, andthe output from the electronic device is provided to the user, eitherthrough viewing of the output visually through the eye or otherwise(e.g., wireless transmission to an external computing device). Data fromthe outside of the body can be transmitted to and/or from the technologydevice in a wireless electromagnetic energy format including, but notlimited to, currently available modalities such as Bluetooth, radiosignals, WiFi, and/or analog and/or digital cellular format signals.This data may be processed and output in the form of a visual displaythat could be projected onto the retina, creating the perception of adigital heads-up display, for example how Google Glass employed thistechnology in an external device. For technology devices configured tosense biometric data (for example, but not limited to, glucose level,electrolyte level, VEGF level, basal metabolic rate, temperature, EEG,EKG, heart rate, intraocular pressure (e.g., for glaucoma patients orglaucoma candidates), ciliary muscle contraction, papillary constructionor dilation, eye movement, blink rate, combinations thereof, and thelike), the data could be collected by the technology device andtransmitted wirelessly by the technology device to an external deviceconfigured to receive the data The electronic technology or the externaldevice may be configured to process the data. For example, beforetransmission, the technology device may transform the data for privacy,security, data transfer efficiency, etc. The external device may beconfigured to process the data, for example because the external devicemay more easily be linked to a power source, cooled, etc. The externaldevice can be configured to provide the data in a format that can beutilized in a health care decision. The data may be accessible by thewearer and/or a doctor or other healthcare professional, for examplelocally and/or through via a secure (e.g., HIPAA-compliant) network.

Another application of this technology could be use by people inenvironmentally challenging environments, for example intelligenceagents, special forces soldiers, astronauts, police officers, and/orfirefighters. Various sensors (e.g., external environmental sensors(e.g., for oxygen level, atmospheric pressure, temperature, infraredheat sensors) and/or internal biometric sensors (e.g., for oxygen level,temperature, heart rate, heart rhythm, glucose level, etc.) could becentrally assessed in an external computing device (e.g., a smartphone),and then transmitted to the intraocular lens to project information ontothe retina in a dashboard type configuration. This information could beused to help them avoid danger and/or more effectively perform theirduties. The technology could also be advantageous to performing anytasks that could benefit from a heads-up display such as surgery (e.g.,recognition and labeling of anatomical structures), mechanical repair(e.g., recognition and labeling of mechanical elements), translation(e.g., from a first language to a second language), businessidentification (e.g., based on user ratings, health ratings, etc.),directions, design, etc.

Generally, as blood glucose increases, the optical properties of theaqueous humor change in a corresponding way, and such change isoptically detectable through a plurality of methods, such as Ramanspectroscopy, optical polarimetry and other methods. Additionally,changes in glucose concentration in the aqueous humor can interact withother devices comprised on or in the system, for example through oncoticpressure/osmotic gradients which can be measured through a plurality ofways, including through a fluorescence resonance energy transfer systembased on Concanavalin A chemistry. Additionally, the system can comprisea passive sensor, and an electric transmitter that can be configured toharness the glucose induced osmotic changes in the aqueous humor byplacing sensors in the system such that their relative distance wouldchange (increase or decrease) in a corresponding manner (for example,the sensors (potentially using two or more capacitor plates) could beconfigured to move closer to each other as glucose levels increased andfurther apart when glucose levels decreased. This relative distancewould be quantifiable (for example as an increase or decrease inelectrical charge of capacitors), and the data could be transmitted forcorrelation to a secondary device). In an example implementation of anelectronic device, a blood glucose monitor may comprise an opticaldetector configured to monitor the optical properties of the aqueoushumor, such as refractive index, optical polarity, and/or spectroscopicproperties in vivo, for example, using an optical detector such as acamera, light sensor, spectrometer, and/or optical polarimeter. Anadvantage of having the optical polarimeter based glucose sensor housedwithin the anterior segment of the eye (and particularly housed insidethe capsular prosthesis device is that it overcomes the artifact inducedby the corneal birefringence and the motion artifact, two of the mostsignificant obstacles to accurate measurement methodology in externaldevices. In another example, the optical detector (spectroscopy unit)can be used to measure the changes of wavelength of light produced in aglucose sensitive fluorescence unit. The changes in optical propertiesof the aqueous humor and/or secondary changes induced in a glucosesensitive fluorescence unit can be correlated to blood glucose level viain situ electronics and/or raw data (e.g., images, histograms, etc.) canbe transmitted to an external device configured to perform thecorrelation. The results can be available on and/or transmitted to anexternal device (e.g., smartphone, smartwatch), which could trigger analarm if the blood glucose value is above and/or below certainthresholds. The blood glucose value can inform the user about the needto ingest sugar, take an insulin shot, etc or could be directlyintegrated into an insulin pump that could automatically dose thepatient according to an algorithm based on a determined dose response asdirected by a physician. Intraocular pressure can also be measured invivo through a secondary device for insertion into the prostheticcapsular device. For example, a secondary device having a passive sensorand an electric transmitter can be positioned in or on the prostheticdevice. The secondary device can be configured to harness the changingintraocular pressure by placing sensors on the secondary device suchthat their relative distance would change (increase or decrease) in acorresponding manner (for example, the sensors (potentially using two ormore capacitor plates) would move closer to each other as theintraocular pressure increased and further apart when intraocularpressure decreased. This relative distance would be quantifiable (forexample as an increase or decrease in electrical charge of capacitors),and the data could be transmitted for correlation to a secondary devicewhich would account for atmospheric barometric pressure, record thedifference and store and/or transmit the data to other devices). Otherbodily parameters that can be measured in the eye include, but are notlimited to, body temperature, heart rate, VEGF levels in maculardegeneration patients, diabetic retinopathy, and retinal vein occlusion.One or all of these values may be visualizable on an external device(e.g., smartphone, smartwatch) and/or via an internal display system(e.g., a heads-up display). These technologies can all be engineered insuch a way as to be housed within the described prosthetic capsulardevice without interfering with the optical properties of the refractiveportion of the device.

The technology device can be used in combination with an intraocularlens. For example, the technology device can be used to control theproperties of the intraocular lens (e.g., the refractive power,ultraviolet (UV) or visual light transmission properties of the IOL,etc.) and/or the properties of the prosthetic capsular device. Forexample, the technology device could be used to control the propertiesof a Calhoun adjustable lens (e.g., as described in U.S. Pat. No.7,988,285, which is hereby incorporated by reference in its entirety),an Elenza lens (e.g., as described in further detail below), etc. Whenused in combination with an IOL, the technology device and the IOL maybe positioned such that the technology device does not interfere withthe sight lines of the IOL (e.g., the technology device does not blockor interfere with light and images transmitted through the IOL and,ultimately, to the retina). The technology device may be around theoutside perimeter edge of the intraocular lens. For example, twoseparate devices, (1) an IOL and (2) the technology device, may each beattached at the outer edge of the IOL. For another example, the IOL canbe manufactured or adapted to have the technology device integral to theIOL at the outer perimeter edge of the IOL. If an IOL has a diameter ofabout 6 mm, a technology device having a width of about 2 mm may beadded around the outer perimeter of the IOL, resulting in the IOL andtechnology device having a total diameter of about 10 mm. Such devicescan vary in size, but the center is preferably at least about 1 mm toserve as the optic, and the entire device (technology device and optic)is preferably small enough to be implanted through an incision into theeye (e.g., the entire device may be similar in size to an IOL).

FIGS. 12A-12C illustrate example prosthetic capsular devices includingtechnology devices and IOLs, and a manner of positioning the technologydevice and the IOL within a prosthetic capsular device. FIG. 12A shows across-section of a ring-like technology device 1202 inside a prostheticcapsular device 1200. FIG. 12A also depicts an IOL 1204 in theprosthetic capsular device 1200. FIG. 12B depicts a front view of anexample intraocular lens 1250 usable in the example prosthetic capsulardevice 1200 shown in FIG. 12A in which the technology device 1250surrounds the outer edge of the IOL 1250 (e.g., surrounds the outer edgeof the optical surface of the IOL 1250). FIG. 12C depicts a top frontperspective of the example intraocular lens 1250. The optical surface1260 is not blocked by the technology device elements of the IOL 1250.The technology device 1250 includes an element 1252 for data output, anelement 1254 for data input or receiving, and an element 1256 for dataprocessing.

The prosthetic capsular device can comprise a material configured toshield the other internal eye structures from the small amount of heator electromagnetic waves that might be generated by the technologydevice. Examples of such materials include silicone and siliconederivatives, acrylic, acrylic derivatives, collamer, biocompatiblemethacrylates (e.g., PMMA), biocompatible polymers, olefins (e.g.,polypropylene), polyimide, combinations thereof (e.g., silicone andpolyimide), and the like. A device comprising a thermally insulatingmaterial such as silicone, polyimide, acrylic, silicon dioxide, flexibleglass, aerogels, combinations thereof (e.g., silicone and polyimide),and/or the like may be used to inhibit or prevent heat transfer due toconduction. Certain device dimensions can be increased to increase heatinsulation, although injectability concerns may also be considered. Areflective and/or opaque material such as polyimide may be used toinhibit or prevent heat transfer due to radiation. Since the device iscapsular, the device can be configured to shield (e.g., selectivelyshield) the ciliary body from heat. In some implementations, theprosthetic capsular device may comprise a combination of silicone andpolyimide (e.g., polyimide overmolded on silicone).

The prosthetic capsular device can comprise a material or have aconfiguration configured to protect the interior of the eye fromunwanted transmission of light. For example, the prosthetic capsulardevice can be designed to shield the posterior segment of the eye fromUV light (for example, therapeutic UV light that is used in highconcentration during procedures such as corneal cross-linking and in therefractive change that occurs through UV light modification of theCalhoun light adjustable lens). There are reports of retinal toxicity toUV exposure during these treatments because the pupil commonly dilatesbeyond the borders of the optic (e.g., greater than about 6 mm), and theUV filter coating on the posterior aspect of these lenses is prone tobeing rubbed off during folding and injecting, leaving the retinaexposed to high doses of UV light transmittance through areas in whichthe coating is scratched off and around the outer border between thepupil edge and the rim of the IOL. By using a prosthetic capsular devicewhich is larger than the pupil (about 6-10.5 mm in minimal width, therewould be no gap between the border of the iris and the IOL. Other sizesof prosthetic capsular devices can also provide UV benefits. Usingestablished materials and methods well known in the art of intraocularlens manufacturing, the UV chromophore could be substantiallyincorporated into the material of the prosthetic capsular device so thisproperty would not be susceptible to failure due to inadvertentmechanical removal (e.g., scratching and/or scraping off) duringfolding, insertion, and/or unfolding of the prosthetic capsular device.

The prosthetic capsular device can have a near-UV and UV blockingability, which can protect the eye from energy or radiation in the formof near-UV or UV light emanating from the environment and utilized fortherapeutic and refractive purposes. Intraocular lenses have been madewith coatings that include UV blocking chromaphores, which can sufferfrom scratching issues upon implantation and other issues, as describedabove. There are currently multiple ophthalmic therapies that utilize UVlight as a treatment modality. For example, the Calhoun light adjustablelens (available from Calhoun Vision, Inc. of Pasadena, Calif.) is anintraocular lens in which the refractive power can be changedpost-operatively through the targeted application of near-UV and UVlight of a specific wavelength for various time periods using aproprietary exposure algorithm. The back surface of the Calhoun lightadjustable lens has a UV blocking layer, but that UV blocking layer isprone to being mechanically damaged (e.g., rubbed or scratched off) uponinsertion of the lens, rendering the UV blocking layer potentiallyineffective such that when the near-UV or UV light treatment isperformed to adjust the lens power post-operatively, the patients areprone to near-UV and UV radiation exposure related complications to thecontents of the posterior segment (ciliary body, retina, optic nerve,etc.). The diameter of the Calhoun lens optic is 6.0 mm, which for manypatients is smaller than the dilated pupil such that UV light may passby the edges of the lens. For these patients, applying a wide beam ofnear-UV or UV light to the lens has the potential to cause UV radiationexposure related complications to the contents of the posterior segment(ciliary body, retina, optic nerve, etc.). If this light adjustable lensis placed inside a prosthetic capsular device that is larger or muchlarger than the dilated pupil and that has the ability to block near-UVand UV light, there could be a reduced likelihood of UV radiationrelated complications during the post-operative treatment.

In some implementations, a capacitor, series of capacitors, and/or arechargeable battery that can be recharged by a device from outside theeye (such as by external induction methods or other electromagneticradiation energy such as radio waves) may supply power to the technologydevice. The battery changer could be incorporated into or adapted to beaffixed to a sleeping device such as a facemask, pillow, mattress,headboard, or bed linen to charge the battery during a user's sleep,sunglasses, a headband, or a hat to charge the battery while the user isoutdoors, and/or spectacle frames or other appropriate devices for whenthe user is indoors. Preferably, the transfer of electricity to power atechnology device either directly or through the charging of a batteryis via an inductive charging system such as through resonant inductivecoupling. For example, the external device could contain an inductioncoil and would be connected to a power source in order to generate analternating electromagnetic field, and the technology device couldcontain a second induction coil configured to harness power from thealternating electromagnetic field generated by the external device andto convert the power into electricity to charge the battery. Theprosthetic capsular device can be designed to shield the posteriorsegment structures, such as the iris, zonules, ciliary body, ciliaryprocess, etc., from heat generated by the charging of batteries throughexternal induction, or the discharge of heat generated by a technologydevice, for example using certain materials and techniques as describedabove. Increased local temperatures can result in inflammation anduveitis, and ultimately limit the biocompatibility of technology device.Utilizing a prosthetic capsular device having optical clarity and withthermal insulating properties (e.g., comprising silicone, siliconederivatives, polyimide, combinations thereof, the like, and/or otherappropriate materials) could provide appropriate thermal insulationwithout adversely affecting visual function.

FIG. 74A illustrates an anterior side perspective view of an exampleintraocular lens 7450. The IOL comprises an optic 7452, a battery 7454on a first radial side of the optic 7452, and electronics 7456 on asecond radial side of the optic 7452. The electronics 7456, providedwith energy from the battery 7454, can affect optical properties of theoptic 7452.

FIG. 74B illustrates an anterior side perspective view of an exampleprosthetic capsular device 7400 containing the intraocular lens 7450 ofFIG. 74A. The device 7400 may include the properties of other devicesdescribed herein, for example but not limited to the devices 5800, 6100,6200, 6300, 6400, 6500, 6600, 6700, 6800, 6900, 7000, 7200. The device7400 comprises a first insulated area 7402 and a second insulated area7404. The insulated areas 7402, 7404 are configured to provide thermalinsulation for parts of a device such as the device 7450 that may heatup. The insulated areas 7402, 7404 may be the same or different (e.g.,having a different thickness or other dimension(s), comprising adifferent material, comprising a different shape, etc.). In someimplementations, the insulated areas 7402, 7404 comprise polyimide.

FIG. 74C illustrates an anterior side perspective view of an exampleprosthetic capsular device 7410 containing an example intraocular lens7460. The device 7410 may include the properties of other devicesdescribed herein, for example but not limited to the device 7400. TheIOL 7460 is similar to the IOL 7450, for example including an optic 7462and electronics 7466, but does not include a battery. The device 7410may comprise or be configured to contain (e.g., comprising sufficientspace radially outward of an optical path and/or contours) a modularbattery 7414. The battery 7414 may interact with electrical leadsextending from the device 7460. The battery 7414 may be rechargeable(e.g., using inductive charging, for example as described herein). Thebattery 7414 may be modularly exchanged, for example using an anchoringsystem as described herein. The device 7460 may be modularly exchanged,for example each new device 7460 powered by the battery 7414, and/or thebattery 7414 may be changed with the device 7460.

FIG. 74D illustrates an anterior side perspective view of an exampleprosthetic capsular device 7420 containing an example intraocular lens7470. The device 7420 may include the properties of other devicesdescribed herein, for example but not limited to the device 7400. TheIOL 7470 is similar to the IOL 7450, for example including an optic 7472and a battery 7474, but does not include electronics. The device 7420may comprise or be configured to contain (e.g., comprising sufficientspace radially outward of an optical path and/or contours) modularelectronics 7412. The electronics 7412 may interact with electricalleads extending from the device 7470. The electronics 7412 may bemodularly exchanged, for example using an anchoring system as describedherein, which can allow upgrading of electronics configured to controlthe optic 7472. The device 7470 may be modularly exchanged, for exampleeach new device 7470 powered by a new battery 7474, and/or theelectronics 7412 may be changed with the device 7470.

FIG. 74E illustrates an anterior side perspective view of an exampleprosthetic capsular device 7430 containing an example intraocular lens7480. The device 7430 may include the properties of other devicesdescribed herein, for example but not limited to the device 7400. TheIOL 7480 is similar to the IOL 7450, for example including an optic7482, but does not include electronics or a battery. The device 7430 maycomprise or be configured to contain (e.g., comprising sufficient spaceradially outward of an optical path and/or contours) a modular battery7414 and/or modular electronics 7412. The battery 7414 may interact withelectrical leads extending from the device 7480. The battery 7414 may berechargeable (e.g., using inductive charging, for example as describedherein). The battery 7414 may be modularly exchanged, for example usingan anchoring system as described herein, which can allow upgrading ofelectronics configured to control the optic 7482. The electronics 7412may interact with electrical leads extending from the device 7480. Theelectronics 7412 may be modularly exchanged, for example using ananchoring system as described herein, which can allow upgrading ofelectronics 7412 configured to control the optic 7482. The device 7480may be modularly exchanged. Each new device 7480 may powered by thebattery 7414 and/or a new battery 7414. Each new device 7480 may becontrolled by the electronics 7412 and/or new electronics 7412.

In some implementations, the device 7410, 7420, 7430 may compriseelectrical leads configured to connect electrical components such aselectronics, batteries, and controllable optics. Although schematicallyillustrated as rectangular and square, modular components may be adaptedto utilize the volume at an end of the device 7410, 7420, 7430.

Referring again to the discussion of virtual and augmented realitydevices herein, the prosthetic capsular devices described herein can beconfigured to contain one or more virtual and/or augmented realitydevices. In some implementations, the devices can include insulation(e.g., thicker and/or different material) generally or specificallywhere virtual and/or augmented reality devices may be inserted. In someimplementations, the devices can include walls, flanges, posts, rails,eyelets, openings, slits, etc. configured to interact with virtualand/or augmented reality devices that can be inserted separate frominsertion of the prosthetic capsular device. In some implementations,the devices can include walls, flanges, posts, rails, eyelets, openings,slits, etc. configured to interact with modular insulating structurescontaining virtual and/or augmented reality devices that can be insertedseparate from insertion of the prosthetic capsular device. In someimplementations, the devices can include a heat sink (e.g., comprisingfins on an outside of the housing structure). Miniature devices orcomponents for virtual and/or augmented that may be shrunk or otherwiseoptimized to be inserted into or interact with the devices describedherein include, for example, sensors (e.g., six-axis position sensors,glucose sensors, light sensors, motion sensors, etc.), display devices(e.g., retinal projectors, stereoscopic displays, external lightdimmers, etc.), data sending and/or receiving devices, and the like.Potential uses for such devices include virtual reality (e.g., a methodof transitioning between a transparent lens and an opaque lens with ascree used for virtual reality), augmented reality (e.g., a heads-updisplay that is implantable into the human capsule for augmentedreality, gaming, etc.), enterprise applications (e.g., a heads-updisplay for training purposes), medical applications (e.g., a method forinserting time-released drugs into the human capsule; blood glucosemonitoring using the fluids naturally present in the eye; a heads-updisplay to assist surgeons with a patient's vital signs, deviceinstructions for use, drug interaction warnings, etc.; pressuremeasurement for early warning of potential glaucoma; liquid lensesallowing autofocus, optical zoom, etc.), gaming applications (e.g.,controls based on eye and/or head movement, focusing, light levels,etc.), directions applications (e.g., a heads-up display that overlaysdirection and navigation cues such as turn-by-turn directions, businesslistings, etc. on top of real-world visual elements), virtual retinaldisplay applications (e.g., a virtual retinal display paired with eyemovement mapping), etc.

The prosthetic capsular device can be designed to be photo-responsive soas to shield the retina from unwanted light, which could provide anumber of uses.

For a first example, people with chronic light-sensitivity may want apermanent decrease in the light transmitted. This would function likepermanent internal sunglasses. A light blocking chromophore of any andall various wavelengths, and of any and all densities of transmissioncould be added to the material formulation, baked into material,contained in a film that can be added as a self-expanding and/orself-contained implant, and/or layered and/or bonded to the prostheticcapsular device, and/or absorbed/adsorbed into/onto the prostheticcapsular device.

For a second example, people might want to have a device in the eye thatdarkens in the light and becomes more clear/transparent in the dark(photogrey, photobrown). Photochromatic materials (e.g., silverchloride, silver halide), which change shape and light absorptionprofile in response to the presence or absence of UV light, could beadded to the material formulation, baked into material, contained in afilm that can be added as a self-expanding and/or self-containedimplant, and/or layered and/or bonded to the prosthetic capsular device,and/or absorbed/adsorbed into/onto the prosthetic capsular device.Photochromatic materials may be combined with light blockingchomophores.

For a third example, people might want to take advantage of the pinholeeffect that can be created by using a small aperture, which can extendthe depth of focus of a given optical system. This can be achieved bydarkening all but the central 1-2 mm (approximately) of the prostheticcapsular device. This effect could be permanent (e.g., comprising anopaque annular mask (e.g., comprising polyvinylidene fluoride (PVDF) andcarbon nanoparticles) embedded in and/or on one or both surfaces of therefractive portion) or transient (e.g., using a color shiftingphotogrey, photobrown, and/or liquid crystal technology to create anannular mask that is opaque or has reduced transmittance). The maskcould have an outer diameter between about 3 mm and about 3.5 mm (e.g.,about 3.25 mm). The mask could have an inner diameter between about 1 mmand about 1.5 mm (e.g., about 1.35 mm). The mask could have a thicknessbetween about 4 μm and about 6 μm (e.g., about 5 μm), although thicknessmay vary based on the number of masks. The mask may comprise a pluralityof microperforations, for example small enough to not allow substantiallight passage or to create diffractive dispersion, but removing enoughmaterial to increase flexibility of the mask. In the transient pinholemask modality where there is good lighting, the patient would be able toread due to the transient pinhole effect that would be created. In lowlighting, the pinhole effect would be removed. Such a device couldimprove near and intermediate vision, increase depth of focus (e.g., byat least about 1.5 D), maintain good distance vision, inhibit creationof competing focal points, glare, halos, night-vision problems, doublevision, ghosting, etc., maintain binocularity for distance, and/ormaintain binocular contrast sensitivity.

With reference to FIGS. 77A-77I, other patients with iris defects maywish to have an iris prosthesis placed at the time of cataract or lensreplacement surgery, or perhaps at a later date following an intraocularinjury. Iris prostheses can be bulky and/or difficult to implant. Theprosthetic capsular devices disclosed herein can be configured toprovide a defined and/or stable anterior opening upon which an irisprosthesis could be positioned to fit on top of the prosthetic capsulardevice and attach to it through a tongue and groove mechanism. The irisprosthesis can be made out of biocompatible materials, and can be madeof various sizes, shapes, and colorings to match the size, shape anddesired cosmetic appearance of the pupil and iris. This could be anentire 12 clock hour prosthetic iris in the case of total or near totalaniridia or loss of iris tissue. Another implementation could be an irisprosthesis that is subtotal (11 clock hours, 10 clock hours, 9 clockhours, 8 clock hours, 7 clock hours, 6 clock hours, 5 clock hours, 4clock hours, 3 clock hours, 2 clock hours, 1 clock hours, or anycombination or variation thereof). Notwithstanding the size of theprosthesis, all would have an element to affix the prosthetic iris tothe prosthetic device.

FIG. 77A-77I illustrates an example prosthetic iris device 7700configured to be coupled to any of the prosthetic capsular devices 5880disclosed herein. In an embodiment, the prosthetic iris device can beimplanted in patients with total or partial loss of iris tissue (forexample, aniridia or iridodialysis). The prosthetic iris device 7700 canbe configured to treat light sensitivity, photophobia, glare, and/orcosmetic flaws in patients. In general, the use of a prosthetic irisdevice configured to be fixated in the sulcus and/or to the sclera canin some instances result in complications and/or may require adequatecapsular support, and therefore such prosthetic iris devices may not besuitable for all patients. In an embodiment, the prosthetic iris device7700 can reduce postoperative complications because the device 7700 doesnot require fixation or suturing to the sulcus and/or the sclera becausethe device 7700 is removably coupled to the prosthetic capsular device7702, and/or may not require attachment to eye tissue. In an embodiment,the prosthetic iris device 7700 can be utilized whether or not there isadequate eye tissue capsular support because the device 7700 can beconfigured to be supported and maintained by the prosthetic capsulardevice 5880.

In an embodiment, the prosthetic iris device 7700 comprises abiocompatible material, for example, silicone, silicone derivatives,acrylic, acrylic derivatives, PMMA, collarmer, polymer, otherbiocompatible optically transparent, semi-transparent and/or opaquematerial, combinations thereof, and the like. In an embodiment, theprosthetic iris device 7700 comprises a circumference of about or thatis no more than 10 mm. In some embodiments, the circumference of theprosthetic iris device 7700 is about or no more than 3.0 mm, 3.5 mm, 4.0mm, 4.5 mm, 5.0 mm, 5.5 mm, 6.0 mm, 6.5 mm, 7.0 mm, 7.5 mm, 8.0 mm, 8.5mm, 9.0 mm, 9.5 mm, 10.0 mm, 10.5 mm, 11.0 mm, 11.5 mm, 12.0 mm, 12.5mm, 13.0 mm, 13.5 mm, 14.0 mm, or 14.5 mm. In an embodiment, theprosthetic iris device 7700 can comprise an iris portion 7706 that isoptically partially transparent and/or opaque. In an embodiment, theiris portion 7706 can comprise a color and/or pattern. In an embodiment,the color and/or pattern of the iris portion 7706 can be configured tohave a similar appearance to a human iris. In an embodiment, the irisportion 7706 is only partially colored and/or patterned to cover only anaffected area of the eye of a patient. In an embodiment, the irisportion 7706 is entirely colored and/or patterned to cover affected andnon-affected areas of the eye. In an embodiment, the prosthetic irisdevice 7700 is not entirely circular in order to cover only portions ofthe eye where there exists iris tissue loss, for example, the prostheticiris device can be an arc or a partial circle of 45 degrees, 90 degrees,135 degrees, 180 degrees, 225 degrees, 270 degrees, or 315 degrees, asillustrated in FIGS. 77D, 77E, 77F (illustrating a 180 degree arc), 77G,77H, 77I (illustrating a 90 degree arc).

In an embodiment, the prosthetic iris device 7700 comprises an opening7704 having a diameter of about or no more than 4 mm. In someembodiments, the opening 7704 comprises a diameter of about or no morethan 1 mm, 1.5 mm, 2 mm, 2.5 mm, 3 mm, 3.5 mm, 4 mm, 4.5 mm, 5 mm, 5.5mm, 6 mm, 6.5 mm, 7 mm, 7.5 mm, 8 mm, 8.5 mm, 9 mm, 9.5 mm, 10 mm, 10.5mm, or 11 mm. In an embodiment, the prosthetic iris device 7700 cancomprise an optically transparent portion in lieu of opening 7704. In anembodiment, the optically transparent portion is integral with respectto the iris portion 7706 to be a single monolithic piece. In anembodiment, the optically transparent portion is removably coupled tothe iris portion 7706. In an embodiment, the optically transparentportion and the iris portion 7706 are part of a single transparentdevice wherein the iris portion 7706 is colored or adapted to bepartially transparent and/or opaque.

In an embodiment, the prosthetic device 7700 comprises a circular or asubstantially circular shape; however, other shapes are possible, suchas square, oval, elliptical, or any other shape. In an embodiment, theiris portion 7706 is circular or substantially circular to resemble thatof a natural human iris shape. In an embodiment, the prosthetic device7700 comprises a curvature that curves toward the opening 7704; however,in other embodiments, the prosthetic device 7700 comprises asubstantially planar configuration. In an embodiment, the prostheticdevice 7700 is flexible and can adapt to the space and shape allocatedby the surgical site. In an embodiment, the prosthetic device 7700 isconfigured to be rolled up, folded, or otherwise deformed for injectioninto the eye through an injector apparatus or otherwise inserted intothe eye. In an embodiment, the prosthetic iris device 7700 is configuredto self-expand to a pre-folded shape. In an embodiment, the prostheticiris device 7700 is configured to be expanded by fluid upon implantationin the eye. In an embodiment, the prosthetic device 7700 is sufficientlyrigid and/or resilient to withstand external pressures and/or forcesexerted by the eye, fluid, eye movement, or the like in order tomaintain or substantially maintain its shape and/or dimension.

In an embodiment, the prosthetic iris device 7700 comprises a ringstructure 7712. In an embodiment, the ring structure 7712 is positionedon the posterior side and/or outer and/or inner perimeter and/or amiddle portion of the prosthetic iris device 7700. In an embodiment, thering structure 7712 is affixed, attached, embedded, overmolded,integrated, glued, or otherwise coupled to the prosthetic capsulardevice. In an embodiment, the ring structure 7712 can comprise an oval,circular, elliptical, or other shape. In an embodiment, a circularshaped ring structure 7712 can be advantageous in order to be able torotate the prosthetic iris device 7700 to a particular orientation,especially, when the iris portion 7706 is an arc or partial circle. Inan embodiment, an oval shaped ring structure that is configured to bethe same or similar shape as the anterior opening to the prostheticdevice can be advantageous in order to prevent the ring structure 7712from rotating on the prosthetic device thereby keeping the prostheticiris in a fixed position. In an embodiment, the ring structure 7712 isconfigured to fit lock and key with the anterior opening of theprosthetic capsular device 7702. In an embodiment, the ring structure7712 can form a friction fit with the anterior opening of the prostheticcapsular device 7702. In an embodiment, the ring structure 7712 can beconfigured to be sutured or other otherwise fixed to the anterioropening of the prosthetic capsular device 7702. In embodiment, theprosthetic iris device 7700 can comprise an outer rim having one or moreflanges and/or tabs that can be sutured to and/or form a friction fitwith and/or tuck in and/or under the anterior opening of the prostheticcapsular device 7702. In an embodiment, the one or more flanges and/ortabs comprises the same material as the of the prosthesis iris device7700 and/or the one or more flanges and/or tabs can comprisepolyimide/prolene haptic type material that could secure the device intoplace.

In certain non-limiting examples, the prosthetic capsular devicesdescribed herein could perform one or more of the following functions:provide a protected prosthetic receptacle having refractive properties,for an intraocular electronic technology device having the ability tosend and receive wireless data, and/or interact with internal orexternal controls through external eye movements, pupil movement,ciliary body contraction, voice, and or controls from other prostheses(contacts, glasses, computer screens, projectors); provide a protectedprosthetic receptacle for battery storage, designed to power electronicintraocular technology; provide a protected prosthetic receptacle for anelectric powered accommodating intraocular lens (such as the Elenzalens); and/or provide a protected prosthetic receptacle for the repairor replacement of intraocular technology including traditional lenses,and electric powered devices as described above.

FIGS. 13-15 illustrate an example of a prosthetic capsular device 1300positioned in an eye 1302. FIG. 13 illustrates a side cross-sectionalside view of an eye 1302 including a prosthetic capsular device 1300. Insome implementations, the prosthetic capsular device 1300 can beconfigured to receive an IOL 1304. The anatomy of the eye 1302 comprisesan outermost layer including the sclera 1306 and the cornea 1308, whichmeet at the cornea-scleral junction or limbus 1309. The iris 1310 isvisible through the transparent cornea 1308 and forms the outer diameterof the pupil 1312, which is an opening in the opaque iris 1310. Theaqueous humor is between the cornea 1308 and the iris 1310. Behind theiris 1310 and pupil 1312 typically (e.g., without prior surgery orphysical issues) sits a natural lens or cataract that occupies the space1316. The natural lens is held in place or suspended by suspensoryligaments (zonules) 1320 connected to the ciliary body 1311. The naturallens comprises lens fibers surrounded by a natural capsular bag 1318,which generally comprises a thin transparent membrane. The spaceanterior to the ciliary body 1311 is the sulcus 1322. The vitreous is aclear gel that fills the vitreous humor between the natural capsular bag1318 and the retina 1313 of the eye 1302. As discussed herein, thenatural lens can be surgically removed for various reasons (e.g.,clouding) and the prosthetic device 1300 can be implanted in the naturalcapsular bag 1318.

In some implementations, the prosthetic device 1300 comprises a ringstructure 1301 coupled to a housing structure 1303. In someimplementations, the ring structure 1301 comprises a material that issufficiently strong to maintain the circumference 1305 or volume of thenatural capsular bag 1318. In some implementations, the ring structure1301 is configured to be sufficiently flexible to adjust and conform tothe natural shape or volume of the natural capsular bag 1318, which canbe asymmetrical. In some implementations, the ring structure 1301 isconfigured to secure the prosthetic device 1300 within the naturalcapsular bag 1318 or other eye region through a friction fit. Forexample, the ring structure 1301 can comprise polyimide, materials knownin intraocular lens manufacturing such as silicone (e.g., MED-6820,available from NuSil Technology LLC of Carpinteria, Calif.), collamer,PMMA, acrylic, and acrylates, materials used in permanent sutureapplications such as polypropylene, nylon, polytetrafluoroethylene(PTFE), and polyester, shape memory or thermal memory materials such asnitinol, chromium cobalt, and shape memory polymers, combinationsthereof, and the like. In some implementations, the ring structure 1301comprises hydrophilic and/or hydrophobic materials.

In some implementations, the housing structure 1303 comprises a materialsufficiently flexible and strong to mechanically maintain and expand thenatural capsular bag 1318 (e.g., to a natural volume of the capsuleprior to removal of the natural lens) and/or to house an IOL 1304 orother device within the housing structure 1303. For example, the housingstructure 1303 can comprise and/or be manufactured from PMMA, acrylic,silicone, collamer, polymer, other biocompatible optically transparentmaterials, combinations thereof, and the like. In some implementations,the housing structure 1303 comprises hydrophilic and/or hydrophobicmaterials.

As illustrated in FIG. 14A, the prosthetic device 1300 can comprise aring structure 1301 that is a continuous loop or circle. In someimplementations, the housing structure 1303 is coupled to the ringstructure 1301 by embedding and/or overmolding (e.g., insert molding,double shot molding, co-injection molding, 2-times injection molding)the ring structure 1301 into the outer edges of the housing structure1303. Compared to bonding (e.g., adhering) the ring structure 1301 andthe housing structure 1303 to each other, overmolding the ring structure1301 to the housing structure 1303 can reduce costs, reduce productionduration, and/or provide a more secure coupling. The material of thehousing structure 1303 (e.g., silicone) can be configured to surround orencase or envelop a portion of the ring structure 1301 at junctionpoints 1406, 1408. In some implementations, the housing structure 1303comprises an opening 1410 in the anterior portion of the housingstructure 1303. In some implementations, the opening 1410 can beconfigured to receive an IOL 1304 and/or other device therethrough to bepositioned in the housing structure 1303.

The prosthetic device 1300 can advantageously comprise less mass and beless bulky relative to other example prosthetic devices disclosedherein. In some implementations, the prosthetic device 1300 isadvantageous because the device 1300 is smaller and stronger relative toother example prosthetic devices disclosed herein. For example, theprosthetic device 1300 can be configured to allow for increasedstructural stability to self-retain structural shape and integritythrough the ring structure 1301 while also reducing volume by reducingthe amount of material used to construct the housing structure 1303. Forexample, the prosthetic device 1300 comprises open space 1402, 1404 oneach side of the housing structure 1303. The prosthetic device 1300thereby can comprise less volume and mass of material than devices thatare diametrically continuous. In some implementations, the open spaces1402, 1404 can allow for and/or promote fibrosis around the ringstructure 1301 and/or in the open spaces 1402, 1404. In someimplementations, fibrosis around the ring structure 1301 and/or in theopen spaces 1402, 1404 can help secure or anchor the prosthetic device1300 to the eye and/or maintain the prosthetic device 1300 in a fixedposition in the eye. In some implementations, fibrosis around theprosthetic device 1300 can reduce or eliminate the need for suturing theprosthetic device 1300 to the eye.

As illustrated in FIG. 14B, the prosthetic device 1350 can lack or befree of a ring structure (e.g., the ring structure 1301). The materialof the housing structure 1353 (e.g., comprising silicone) can beconfigured to appose interior sidewalls of the natural capsular bag atjunction points 1456, 1458. In some implementations, the housingstructure 1353 comprises an opening 1460 in the anterior portion of thehousing structure 1353. In some implementations, the opening 1460 can beconfigured to receive an IOL 1304 and/or other device therethrough to bepositioned in the housing structure 1353. The prosthetic device 1350 canadvantageously comprise less mass and be less bulky relative to otherexample prosthetic devices disclosed herein. The prosthetic device 1350can be combined with a second component such as a capsular tension ringconfigured to hold the device 1350. For example, the ring could beimplanted first, and then the device 1350 could be coupled to the ringin situ.

During implantation, the prosthetic device 1300 can generally be foldedor rolled up along the axis 1412 of the prosthetic device 1300. Afterthe device 1300 is rolled up or folded, the prosthetic device 1300 canbe positioned within a insertion or injector device. In someimplementations, the insertion or injector device comprises a wide firstend opening and becomes progressively narrower until terminating at anarrow second end opening. In some implementations, the wide first endopening comprises a substantially oval configuration and the narrowsecond end opening comprises an arcuate (e.g., substantially circular,elliptical, etc.) configuration. In some implementations, the wide firstend opening is configured to receive the prosthetic device 1300 and, asthe prosthetic device 1300 is pushed through the funnel or taperingportion of the insertion or injector device, the prosthetic device 1300is compressed as the device advances towards the narrow second endopening.

In some implementations, the prosthetic device 1300 is inserted orsqueezed or compressed into the insertion device without folding orrolling up the prosthetic device 1300. After positioning the distal endof the insertion device in the natural capsular bag 1318 of the eye1302, an implantation tool can be positioned within the insertion deviceto push the prosthetic device 1300 through and out of the insertiondevice and into the natural capsular bag 1318. By having less mass, inparticular lateral to the axis 1412, the prosthetic device 1300 can beinserted through a narrower insertion device because the prostheticdevice 1300 can be rolled up, folded, or compressed into a more compactform. A narrower insertion device allows a smaller incision in the eye,which can be beneficial to the patient. Generally, smaller incisions inthe eye require less healing time and, in some cases, may be closedwithout sutures.

As illustrated in FIG. 14A, the prosthetic device 1300 comprises ahousing structure 1303 that is narrower than other examples ofprosthetic devices disclosed herein. In some implementations, thenarrower configuration of the housing structure 1303 can be advantageousfor insertion of an IOL into the housing structure 1303. For example, anarrower housing structure 1303 can inhibit or limit or prevent rotationof an IOL 1304 within the housing structure 1303. By limiting,inhibiting, or preventing the rotation of the IOL 1304 within thehousing structure 1303, a surgeon or other user can be substantiallycertain that the position of the IOL 1304 will remain substantiallyconstant over time. In some cases, changes in the IOL 1304 position overtime can cause the patient to experience blurred or unclear vision.Limiting rotational freedom of the IOL 1304 within the housing structure1303 can advantageously inhibit or prevent vision issues that mightotherwise develop over time. For example, in toric IOLs, every 1 degreeof rotation causes loss of approximately 3% of astigmatic correctionsuch that if the lens rotates 15°, almost half of the corrective effectcan be lost. In some instances, a surgeon or other user may not need torotate an IOL 1304 within the housing structure 1303 to achieve aparticular orientation if the surgeon or user can align the prostheticdevice 1300 such that an IOL 1304 positioned in the device 1300automatically or necessarily assumes the orientation.

With reference to FIGS. 15-18, the housing structure of the prostheticdevice can have various shapes and/or sizes. Housing structures havingvarious shapes and/or sizes can be advantageous because different shapesand/or sizes can accommodate different types of IOLs and/or otherdevices to be positioned within the housing structure. Some patients maybenefit from a housing structure that is as compact as possible. Forexample, compact housing structures can include, without limitation,housing structures having a shape that is more spherical or circular orrounded in nature, or having tapered or angled sides. In these types ofsituations, implanting a prosthetic device having a housing structurethat is as compact as possible can advantageously accommodate thesurgical needs of the patient. For example, some patients have smallernatural capsular bags may benefit from a prosthetic device having acompact housing structure.

In some situations, a patient may benefit from two or more IOLs and/ordevices to be positioned in the housing structure of the prostheticdevice. In these types of situations, it could be beneficial for theprosthetic device to comprise a housing structure that provides for asmuch capacity as possible. For example, some patients may require ordesire two or more IOLs to be positioned within the housing structure.Therefore, it may be beneficial to provide a housing structure that isless compact and is more cylindrical in order to provide more space forreceiving two or more IOLs or other devices within the housingstructure. In certain implementations, a housing structure that allowsfor the positioning of one or more IOLs or other devices at specificpositions in the x, y, and/or z planes within the housing structure maybe advantageous. For example, the surgeon can advantageously position anIOL in the anterior portion of the housing structure, or in theposterior portion of the housing structure, or in the middle portion ofthe housing structure.

In certain cases, the surgeon may find it difficult to ensure that theIOL is positioned within a desired portion of the housing structure. Incertain implementations, the housing structure comprises ridges orgrooves within the interior portion of the housing structure, which canhelp ensure that an IOL maintains a specific position within the housingstructure. In some implementations, the housing structure comprises apyramid-like configuration (e.g., frusto-pryamidal), which can helpensure that the IOL maintains a certain position within the housingstructure. For example, the housing structure can have a width that isnarrower at the anterior portion than at the posterior portion. Incertain instances, an IOL or other device may comprise a certaindiameter or width that inhibits or prevents the IOL or other device frommoving past a certain point in the anterior portion due to the narrowwidth of the anterior portion of the housing structure. The housingstructure may comprise a configuration wherein the posterior portion ofthe housing structure is narrower in width than the anterior portion ofthe housing structure.

FIG. 16 illustrates a prosthetic device 1600 comprises a housingstructure 1602 having tapered sides 1604A, 1604B. The housing structure1602 is coupled to the ring structure 1606 at the apices of the taperedsides 1604A, 1604B. As described above with respect to the ringstructure 1301, the ring structure 1606 can be embedded or attached orotherwise coupled to the housing structure 1602. As discussed above, theprosthetic device 1600 can be advantageous in certain situations where acompact housing structure is required. By having tapered sides 1604A,1604B, the housing structure 1602 occupies less volume. This type ofconfiguration may be well-suited for natural capsular bags having smallvolume capacity, or having tapered side regions, or other conditionsthat may benefit from a prosthetic device 1600 having a compact housingstructure 1602. The prosthetic device 1600 can be advantageous forpositioning an IOL and/or other device within the housing structure 1602at a particular position in the housing structure 1602. For example, thetapered sides 1604A, 1604B can be configured to inhibit or preventmigration of the IOL and/or other devices into the anterior and/orposterior regions of the housing structure 1602. Although notillustrated, as described herein, the anterior end or face or surface ofthe device 1600 may comprise an opening through which an IOL and/orother devices can be inserted. The opening can be circular (e.g., likethe opening 1410), may conform to the shape of the anterior surface, ortake other shapes. The absence of illustration of an opening in ananterior face of example prosthetic devices herein is for clarity ofother aspects of such devices and does not mean that such device lackssuch an opening.

FIG. 17 illustrates a prosthetic device 1700 comprising a housingstructure 1702 having a generally cylindrical (e.g., without material ontwo opposite sides of the cylinder) configuration in which the sidewalls 1704A, 1704B are perpendicular or substantially perpendicular toat least one of the anterior face 1708 and the posterior face 1710 ofthe housing structure 1702. As discussed above, it can be advantageousfor the housing structure 1702 to be configured with a shape thatincreases or maximizes internal volume of or capacity within the housingstructure 1702 while still maintaining possible benefits of a ringstructure 1706 and housing structure 1702. By increasing or maximizingcapacity, the housing structure 1702 can be configured to receive two ormore IOLs and/or other devices that may be implanted in an eye of apatient. The configuration of the prosthetic device 1700 can beadvantageous for patients having natural capsular bags that have largevolume capacity. The housing structure 1702 can be configured to take upadditional space within the natural capsular bag, for examplemechanically expanding to maintain the shape or volume of the naturalcapsular bag. In some implementations, the housing structure 1702comprises side walls 1704A, 1704B that have a curvature that is the sameor substantially the same as the curvature of the ring structure 1706.In some implementations, the housing structure 1702 is coupled to thering structure 1706 at the side walls 1704A, 1704B. In someimplementations, the side walls 1704A, 1704B are embedded, attached, orotherwise coupled to the ring structure 1706.

FIG. 18 illustrates a prosthetic device 1800 comprising a housingstructure 1802 having side walls 1804A, 1804B that form an angle withrespect to the anterior face 1808 that is obtuse or greater than 90°,and the side walls 1804A, 1804B form an anterior angle with respect tothe posterior face of the housing structure 1802 that is acute or lessthan 90°. The angles formed by the faces 1804A, 1804B may be the same ordifferent. As discussed above, it can be advantageous for the housingstructure 1802 to comprise a pyramid-like configuration in which a widthat the anterior portion of the housing structure 1802 is smaller thanthe width at the posterior portion of the housing structure 1802. Forexample, certain IOLs and/or other devices may comprise a diameter orwidth or other dimension that interacts with the housing structure 1802to inhibit or prevent the IOL and/or other device from migrating beyonda certain point within a certain portion of the housing structure 1802.For example, the narrower anterior portion of the housing structure 1802can be configured to inhibit or prevent an IOL and/or other devicehaving a certain dimension from migrating anteriorly beyond a certainpoint within the housing structure 1802.

In some implementations, a surgeon or other user may desire to implanttwo or more IOLs and/or other devices within the housing structure 1802.The surgeon or other user may desire that a first IOL or other device bespaced from a second IOL or other device within the housing structure1802. To accommodate the foregoing, the first IOL or other device can bepositioned in the posterior portion of the housing structure 1802, butis inhibited from migrating towards the anterior portion of the housingstructure 1802 (e.g., by comprising a width, diameter, or otherdimension that is too large for the smaller anterior portion), and thesecond IOL or other device can be positioned in the anterior portion ofthe housing structure 1802 (e.g., by comprising a width, diameter, orother dimension that is small enough to fit in the smaller anteriorportion). As illustrated in FIG. 18, the housing structure 1802 can becoupled to a ring structure 1806. In certain implementations, the ringstructure 1806 is embedded, attached, or otherwise coupled to thehousing structure 1802 (e.g., to the side walls 1804A, 1804B of thehousing structure 1802). In certain implementations, the housingstructure 1802 comprises side walls 1804A, 1804B having curvatures thatare the same or substantially the same as the curvature of the ring1806. In certain implementations, the sidewalls 1804A, 1804B aregenerally flat between rounded edges and the housing structure 1802 isattached to the ring structure 1806 at edge points of the housingstructure 1802.

FIGS. 19-22C illustrate example prosthetic devices comprising a housingstructure that is coupled to a sinusoidal or zigzag or undulating orwave-like ring structure as opposed to a circular, oval, or otherwisearcuate configuration. In certain implementations, the ring structure isin a plane that is substantially parallel to the anterior surface of thehousing structure. In some implementations, the ring structure comprisesa shape that ripples in a direction perpendicular or substantiallyperpendicular to the anterior surface. In some implementations, the ringstructure comprises a shape that ripples both in a plane that isparallel to the anterior surface and in a direction substantiallyperpendicular to the anterior surface. The ring structure can beconfigured to have a sinusoidal shape in a horizontal direction relativeto the anterior surface, in a vertical direction relative to theanterior surface, or in both a horizontal direction and a verticaldirection relative to the anterior surface.

The sinusoidal shape of the ring structure may increase securement oranchoring of the ring structure to the natural capsular bag. Forexample, the shape and dimensions of the natural capsular bag variesgreatly from patient to patient. In some instances, the shape of thenatural capsular bag of a patient is not completely circular or oval orelliptical in shape. In some instances, the shape of the naturalcapsular bag is irregular and/or asymmetrical. A ring structure having asinusoidal shape can flex and conform to the shape of the naturalcapsular bag, which can provide improved positioning within an irregularnatural capsular bag shape. In certain implementations, the tips orapices or radially outward portions of the sinusoidal wave areconfigured to engage the natural capsular bag. The shape of thesinusoidal ring structure may be substantially regular (e.g., as shownin FIGS. 19-22C) or may vary. For example, some apices may have a largerdiameter than other apices. For another example, some apices may bebiased in an anterior direction and other apices may be biased in aposterior direction. For another example, some apices may comprise abend and other apices may comprise a coil or ring (e.g., as shown inFIGS. 21-22C). In certain implementations, a ring structure having asubstantially circular or oval or elliptical configuration may not beable to conform to an irregular and/or asymmetrical shape of a naturalcapsular bag as well as a ring structure having a sinusoidal shape.

In some implementations, the sinusoidal shape of the ring structure canbe substituted with a coil structure that forms the ring structurearound the housing structure.

FIG. 19 illustrates an example prosthetic device 1900 comprising asinusoidal ring structure 1906 and a housing structure 1902. The housingstructure 1902 can comprise an opening 1910 in the anterior surface1912. The opening 1910, as described in other examples herein, can beconfigured to receive an IOL or other device (e.g., technology device)therethrough in order to position the IOL or other device in the housingstructure 1902. In some implementations, the ring structure 1906 isconfigured to be coupled to the housing structure 1902. In the exampledevice 1900 illustrated in FIG. 19, the ring structure 1906 is embeddedwithin the housing structure 1902 at portions 1908A, 1908B such that thering structure 1906 is partially encapsulated by the housing structure1902. In certain implementations, the ring structure 1906 is attached orcoupled to the housing structure 1902. In certain implementations, thehousing structure 1906 is attached to the interior portion of thehousing structure 1902. In certain implementations, the ring structure1906 is attached to the exterior portion of the housing structure 1902.The ring structure 1906 may be non-undulating or substantially arcuatewhere the ring structure 1906 is configured to be coupled to the housingstructure 1902, for example to reduce manufacturing complexity. The ringstructure 1906 may continue the sinusoidal shape for engagement of morematerial with the housing structure 1902 at the portions 1908A, 1908B.The ring structure 1906 may have a different sinusoidal shape forengagement with the housing structure 1902 at the portions 1908A, 1908B,for example to lock into place at a particular orientation.

FIG. 20 illustrates an example of a prosthetic device 2000. In someimplementations, the prosthetic device 2000 comprises a housingstructure 2002 that is coupled to a ring structure 2006. In contrast tothe prosthetic device 1900 of FIG. 19, the prosthetic device 2000 can beconfigured to have an elongate housing structure 2002 that has an evenlarger length along the axis 2008 than width along the axis 2010, orlength to width ratio. As described above, it can be advantageous tohave a prosthetic device 2000 having a housing structure 2002 that iselongate in the axis 2008 in order to accommodate IOL and/or otherdevices to be positioned in the housing structure 2002. A housingstructure 2002 that is elongate in the axis 2008 may advantageously takeup additional space within the natural capsular bag such that thehousing structure 2002 can be better suited for mechanically expandingand/or maintaining the natural shape of the natural capsular bag, butthe smaller dimensions in the axis 2010 can reduce the volume of thedevice 2000 for insertion. The housing structure 2002 can be configuredto be elongate in the axis 2010. As discussed above, a housing structure2002 that is wider along the axis 2010 than the axis 2008, or viceversa, can be configured to receive IOLs and other devices having awider diameter or width or other dimension. In some implementations, theprosthetic device 2000 can be elongate both in the axial direction 2008and the axial direction 2010 (e.g., having a shape of a rounded square).

FIGS. 21-22B illustrate examples of prosthetic devices 2100, 2200, 2250,respectively, comprising a housing structure 2102, 2202 that is coupledto a ring structure 2106, 2206. In some implementations, the ringstructure 2106, 2206 comprises eyelets 2108A, 2108B, 2108C, 2108D. Incertain implementations, the eyelets 2108A, 2108B, 2108C, 2108D can beconfigured to receive a suture to allow the surgeon or other user tosuture the ring structure 2106 to the natural capsular bag, iris,ciliary body, sclera, or other eye tissue. In some implementations, theeyelets 2108A, 2108B, 2108C, 2108D can be configured to allow and/orpromote fibrosis formation within the eyelets 2108A, 2108B, 2108C, 2108Dto secure or anchor the prosthetic device 2100, 2200, 2250 in thenatural capsular bag. In certain implementations, the prosthetic device2100, 2200, 2250 comprising eyelets 2108A, 2108B, 2108C, 2108D can beadvantageous in situations in which the prosthetic device 2100, 2200,2250 is implanted in the eye of a patient for long periods of time. Asthe eye ages, the eye changes in shape and elasticity. Eyelets 2108A,2108B, 2108C, 2108D that allow a surgeon or other used to secure thering structure 2106, 2206 to an eye by suturing may advantageouslyproperly secure the prosthetic device 2100, 2200, 2250 to the eye of apatient throughout these changes. By suturing the ring structure 2106,2206 to the eye, the prosthetic device 2100, 2200, 2250 can be inhibitedor prevented from migrating to a different position in the eye as theeye changes shape and/or elasticity due to age. The eyelets 2108A,2108B, 2108C, 2108D may comprise bends that are at least 360° at anexterior point or loops or coils or in the ring 2106, which can increasespring force at the apices, which can provide increased conformation tothe natural capsular bag.

FIG. 22A illustrates an example of a prosthetic device 2200. In someimplementations, the prosthetic device 2200 comprises a housingstructure 2202 that is coupled to at least two ring portions 2206A,2206B. In contrast to the device 2100 in which the ring structure 2106is embedded in the housing structure 2102, the ring portions 2206A,2206B can be attached or coupled to the housing structure 2202 atjunction points 2210A, 2210B, 2210C, 2210D such that the ring portions2206A, 2206B are not substantially embedded in the housing structure2202. In some implementations, the housing structure 2202 can compriseedge portions 2208A, 2208B that do not comprise or lack or are free ofring portions 2206A, 2206B along substantially the entire length of theedge portions 2208A, 2208B. In some implementations, the edge portions2208A, 2208B are configured to be more easily folded by not embedding orbeing coupled to a ring portions 2206A, 2206B across the entire lengthof the edge portions 2208A, 2208B. The ring portions 2206A, 2206B may bethe same or different, for example comprising different shapes,materials, dimensions, bend types, combinations thereof, and the like.The ring portions 2206A, 2206B may be configured for a specificorientation in the eye (e.g., the ring portion 2206A medial, the ringportion 2206A being dorsal, etc.).

In some implementations, the edge portions 2208A, 2208B comprisesufficient mechanical structural support to inhibit or prevent thehousing structure 2202 from collapsing under the forces exerted by thenatural capsular bag of the eye. For example, the edge portions 2208A,2208B may comprise one or more raised ridge regions along a length ofthe edge portions 2208A, 2208B. As discussed above, reducing the amountof mass and/or material utilized to construct the prosthetic device 2200can allow the device 2200 to be rolled up or folded along the lengthwiseaxis 2212 in such a way that the prosthetic device 2200 may be insertedinto an insertion tool having a small diameter. By utilizing aninsertion tool having a small diameter, the surgeon or other user canmake an incision in the eye that is less than about 3.5 mm, less thanabout 3.4 mm, less than about 3.3 mm, less than about 3.2 mm, less thanabout 3.1 mm, less than about 3 mm, less than about 2.9 mm, less thanabout 2.8 mm, less than about 2.7 mm, less than about 2.6 mm, less thanabout 2.5 mm, less than about 2.4 mm, less than about 2.3 mm, less thanabout 2.2 mm, less than about 2.1 mm, less than about 2 mm, less thanabout 1.9 mm, or less than about 1.8 mm.

FIG. 22B illustrates an example of a prosthetic device 2250. In someimplementations, the prosthetic device 2250 comprises a housingstructure 2252 that is coupled to at least two ring portions 2256A,2256B. In contrast to the device 2100 in which the ring structure 2106is embedded across an entire length of a portion of the housingstructure 2102, and in contrast to the device 2200 in which the ringportions 2206A, 2206B are attached or coupled to the housing structure2202 at junction points 2210A, 2210B, 2210C, 2210D such that the ringportions 2206A, 2206B are not substantially embedded in the housingstructure 2202, the device 2250 comprises ring portions 2256A, 2256Bthat are partially embedded in the housing structure 2252 by at leastone of end anchors 2260A, 2260B, 2260C, 2260D (e.g., into end portions2258A, 2258B of the housing structure 2252) and longitudinal anchors2262A, 2262B (e.g., into side portions 2258C, 2258D of the housingstructure 2252). The end anchors 2260A, 2260B, 2260C, 2260D can extendinto edge portions 2258A, 2258B of the housing structure 2252 by thesame amount or by different amounts. In some implementations, at leastone of the end anchors 2260A, 2260B, 2260C, 2260D comprises an arcuateshape that changes direction at least once (e.g., an “S” shape). Theshapes of the end anchors 2260A, 2260B, 2260C, 2260D may be the same ordifferent. The longitudinal anchors 2262A, 2262B can extend along anentire length of the side portions 2258C, 2258D of the housing structure2252 (e.g., as shown in FIG. 22B) or partially along a length of theside portions 2258C, 2258D of the housing structure 2252. Thelongitudinal anchors 2262A, 2262B can extend along the side portions2258C, 2258D of the housing structure 2252 by the same amount or bydifferent amounts. In some implementations, at least one of thelongitudinal anchors 2262A, 2262B comprises a shape that changesdirection at least once (e.g., turning towards a longitudinal center ofthe housing structure 2250). The shapes of the longitudinal anchors2262A, 2262B may be the same or different. One or more of the endanchors 2260A, 2260B, 2260C, 2260D and/or the longitudinal anchors2262A, 2262B may comprise a shape configured to provide secure anchoringin the housing structure 2252 (e.g., an undulating shape, a coil shape,a direction-changing shape, etc.). The end anchors 2260A, 2260B, 2260C,2260D and the longitudinal anchors 2262A, 2262B may be connected in oneor more locations. For example, instead of or in addition to beingconnected proximate to the points of entry into the housing structure2252, the end anchors 2260A, 2260B, 2260C, 2260D and the longitudinalanchors 2262A, 2262B may be connected in the housing structure 2252inward of the edges of the housing structure 2252.

FIG. 22B also illustrates example dimensions of the device 2250. Theexternal length 2270 of the housing structure 2252 may be between about9 mm and about 11 mm (e.g., between about 9.5 mm and about 10 mm). Theinternal length 2272 of the housing structure 2252 may be between about8 mm and about 10 mm (e.g., about 9 mm). The external width 2274 of thehousing structure 2252 may be between about 6 mm and about 8 mm (e.g.,about 7 mm). The external length to width ratio (e.g., 2270/2274) may bebetween about 1.125:1 and about 2:1 (e.g., about 1.4:1). The internalwidth 2276 of the housing structure 2252 may be between about 6 mm andabout 7 mm (e.g., about 6.5 mm). The length or width 2278 of the openingin the anterior side may be between about 5 mm and about 7 mm (e.g.,about 6 mm). As discussed herein, the opening may have shapes other thancircular and appropriate dimensions in accordance with such shapes. Theexternal width 2280 of the device 2250 (e.g., including the housingstructure 2252 and the ring portions 2256A, 2256B) may be between about9 mm and about 11 mm (e.g., between about 9.5 mm and about 10 mm). Thedistance 2282 between the housing structure 2252 and the outermost partof the ring portions 2256A, 2256B may be between about 1 mm and about 2mm (e.g., about 1.5 mm). Referring to FIG. 22C, which is a sideperspective view of the device 2250, the external thickness or depth orheight 2284 of the housing structure 2252 may be between about 2 mm andabout 3 mm (e.g., about 2.5 mm).

FIGS. 23-25 illustrate an example of a prosthetic device 2300 comprisinga housing structure 2301 that is coupled to an anterior ring structure2304 and a posterior ring structure 2302. In some implementations, theanterior ring structure 2304 is coupled to the anterior portion of thehousing structure 2301 and the posterior ring structure 2302 is coupledto the posterior portion of the housing structure 2301. In someimplementations, the ring structures 2304, 2302 can be coupled to otherareas of the housing structure 2301. For example, the anterior ringstructure 2304 can be positioned slightly posterior from the anterioredge of the anterior portion of the housing structure 2301 and theposterior ring structure 2302 can be positioned slightly anterior fromthe posterior edge of the posterior portion of the housing structure2301. As described above, the ring structures 2304, 2302 can be embeddedin the housing structure 2301 or the ring structures 2304, 2302 can beattached or coupled in some other fashion to the housing structure 2301.In some implementations, the housing structure 2301 can comprise anopening 2404 in the anterior surface of the housing structure 2301. Insome implementations, the opening 2404 can be configured to receivetherethrough an IOL 2303 or other device that is to be positioned withinthe housing structure 2301.

As illustrated in FIG. 23, the prosthetic device 2300 can be configuredto be positioned in the natural capsular bag 1318 such that the ringstructures 2304, 2302 are oriented parallel or substantially parallel tothe plane of the circumference 1305 of the natural capsular bag 1318. Asillustrated in FIG. 23, the prosthetic device 2300 is not positionedsuch that the ring structures 2304, 2302 are oriented in ananterior-posterior direction 2312; however, in some implementations, theprosthetic device can be configured such that the ring structures 2304,2302 can be oriented in an anterior-posterior direction 2312. If thering structures 2304, 2302 are positioned in an anterior-posteriordirection, the ring structures 2304, 2302 may be configured to besmaller, oval, and have dimensions less than the diameter of the ringstructures shown in FIG. 23 and/or may be positioned substantially nearthe top region 2311 and the bottom region 2310 of the natural capsularbag 1318 (e.g., radially outward of the pupil such that the ringstructures 2304, 2302 are not in the optical path). In someimplementations, the ring structures 2304, 2302 can advantageously beconfigured to provide the prosthetic device 2300 with sufficientmechanical force to mechanically expand and/or maintain the naturalshape of the natural capsular bag 1318 and to inhibit or prevent thecapsular bag 1318 from collapsing. In some implementations, the ringstructures 2304, 2302 can be helpful in securing the housing structure2301 in the natural capsular bag 1318 in a fixed or substantially fixedposition.

In some implementations, the ring structures 2304, 2302 can be helpfulin maintaining the shape and/or size of the housing structure 2301and/or can inhibit or prevent the housing structure 2301 from at leastpartially or fully collapsing (e.g., radially inwardly contracting) dueto the forces exerted by or on the natural capsular bag 1318. In someimplementations, the ring structures 2304, 2302 can be helpful incausing the prosthetic device 2300 to return to an expandedconfiguration (e.g., to self-expand) after the prosthetic device 2300has been rolled up and inserted into the insertion tool for implantationin the natural capsular bag 1318. As discussed above, the prostheticdevice 2300 is an advantageous design because the prosthetic device 2300comprises less mass and housing material as compared to other examplesdisclosed herein. A prosthetic device 2300 having less mass and materialcan be rolled up into a more compact form for placement in a smallerinsertion tool, thereby allowing a smaller incision in the eye.

FIGS. 26-30 illustrate an example of a prosthetic device 2600 comprisinga housing structure 2608 that is coupled to an anterior ring structure2606 at an anterior portion of the housing structure 2608, that iscoupled to a posterior ring structure 2602 at a posterior portion 2612of the housing structure 2608, and that is coupled to an intermediatering structure 2604 at an intermediate portion of the housing structure2608 between the anterior portion of the housing structure and theposterior portion of the housing structure. The intermediate portion ofthe housing structure 2608 may be at a substantial midpoint between theanterior and posterior portions of the housing structure 2608, may becloser to the anterior portion of the housing structure 2608, or may becloser to the posterior portion of the housing structure 2608. In someimplementations, the anterior and posterior ring structures 2606, 2602comprise a diameter or dimension that is substantially the same whereasthe intermediate ring structure 2604 comprises a diameter or dimensionthat is greater than the diameters or dimensions of the posterior andanterior ring structures 2606, 2602. In some implementations, the ringstructures 2602, 2604, 2606 each comprises a diameter or dimension thatis substantially the same. In some implementations, the anterior ringstructure 2606, the posterior ring structure 2602, and the intermediatering structure 2604 each comprises a diameter or dimension that isdifferent from each other.

In some implementations, the prosthetic device 2600 is positioned withinthe natural capsular bag 1318 in a plane that is parallel orsubstantially parallel to the plane of the circumference 1305 of thenatural capsular bag 1318. As illustrated in FIG. 26, the prostheticdevice 2600 is not positioned in an anterior-posterior direction. Insome implementations, the prosthetic device 2600 comprises an opening2702 in the anterior surface 2614. In some implementations, the opening2702 is configured to receive therethrough an IOL 2610 and/or otherdevice to be positioned in the housing structure 2608.

In some implementations, the three ring structures 2602, 2604, 2606coupled to the housing structure 2608 can better secure the prostheticdevice 2600 within the natural capsular bag 1318, for example due toincreased surface area with which the prosthetic device 2600 can contactthe interior surface of the natural capsular bag 1318. In someimplementations, the ring structures 2602, 2604, 2606 can be configuredto provide greater mechanical force to expand and maintain the naturalshape of the natural capsular bag 1318 and inhibit or prevent thenatural capsular bag 1318 from collapsing under the forces of or on thenatural capsular bag 1318. In some implementations, the three ringstructures 2602, 2604, 2606 can be configured to take up additionalvolume and space within the natural capsular bag 1318 to expand andmaintain the natural shape of the natural capsular bag 1318.

FIGS. 29 and 30 illustrate an example of a prosthetic device 2900. Theprosthetic device 2900 is similar to the prosthetic device 2600 in thatthe prosthetic device 2900 comprises three ring structures 2902, 2904,2906 that are coupled to a housing structure 2901. The three ringstructures 2902, 2904, 2906 are also connected to each other through aplurality of connecting structures or struts 2908. In someimplementations, the connecting structures 2908 are configured tostabilize and maintain the position and/or structure of the three ringstructures 2902, 2904, 2906. In some implementations, stabilizing thethree ring structures 2902, 2904, 2906 can allow the prosthetic device2900 to better mechanically expand and maintain the natural shape and/orsize of the natural capsular bag. The connecting structures 2908 can behelpful in inhibiting or preventing the housing structure 2901 fromcollapsing under the forces of the natural capsular bag. Similar to theother examples of the prosthetic device disclosed herein, the housingstructure 2901 can be configured to receive an IOL 2912 and/or otherdevices in the housing structure 2901. The connecting structures 2908may comprise straight bars, coils, sinusoidal structures, otherappropriate shapes, combinations thereof, and the like. The connectingstructures 2908 may be oriented substantially in an anterior-posteriordirection, may be circumferentially angled like triangle supports, maybe radially angled to account for diameter differences, combinationsthereof, and the like. The connecting structures 2908 between the rings2902, 2904 may be aligned (e.g., in a same circumferential position)with the connecting structures 2908 between the rings 2902, 2904,misaligned (e.g., in different circumferential positions) with theconnecting structures 2908 between the rings 2902, 2904, andcombinations thereof. The prosthetic device 2900 may comprise connectingstructures connecting the rings 2902, 2906. The connecting structures2908 may comprise a same material as the ring structures 2902, 2904,2906 (e.g., making manufacturing and/or coupling easier) or a differentmaterial than the ring structures 2902, 2904, 2906 (e.g., allowingmaterial more suitable for support such as having high rigidity to beused for the connecting structures 2908).

FIGS. 31-33 illustrate an example of a prosthetic device 3100. Theprosthetic device 3100 comprises a housing structure 3106 coupled to ananterior ring structure 3102 and a posterior ring structure 3104. Thering structures 3102, 3104 connect with each other at junction points3114, 3116. The junction points 3114, 3116 can be substantially evenlyspaced or opposite about the circumference of the ring structures 3102,3104 or asymmetrically spaced about the circumference of the ringstructures 3102, 3104. Fewer (e.g., one) or more (e.g., greater thantwo) junction points are also possible. In some implementations, theanterior ring structure 3102 is coupled to an anterior portion of thehousing structure 3106 and the posterior ring structure 3104 is coupledto a posterior portion of the housing structure 3106. In someimplementations, the ring structures 3102, 3104, where connected to thehousing structure 3106, are in planes that are parallel or substantiallyparallel with each other. Portions of the ring structures 3102, 3104that are not connected to the housing structure 3106 are intersect eachother at the junction points 3114, 3116. In some implementations, thering structures 3102, 3104 are continuous monolithic structures. In someimplementations, the ring structures 3102, 3104 comprise two, three, ormore components that are coupled or fused together to form the ringstructures 3102, 3104.

In some implementations, ring structures 3102, 3104 connected atjunction points 3116, 3114 can provide better structural support andintegrity for the prosthetic device 3100. By strengthening thestructural integrity, the prosthetic device 3100 can be configured tobetter mechanically maintain and/or expand the natural capsular bag1318. The structural integrity provided by the connected ring structures3102, 3104 can help inhibit or prevent the housing structure 3106 fromcollapsing under the forces of the natural capsular bag 1318. In someimplementations, the ring structures 3102, 3104 can be configured to bespring-like such that the ring structures 3102, 3104 can be configuredto flex radially in and out depending on the forces exerted on theprosthetic device 3100. In this regard, the ring structures 3102, 3104can be configured to better hold the shape of the natural capsular bag1318 and/or can be configured to inhibit or prevent or mitigate thetendency for the prosthetic device 3100 to rotate in the naturalcapsular bag 1318 or eye.

FIGS. 34 and 35 illustrate examples of prosthetic devices 3400, 3500,respectively. With reference to FIG. 34, the prosthetic device 3400comprises a housing structure 3402 that is coupled to a ring structure3406. In some implementations, the housing structure 3402 comprises anopening 3401 that is configured to receive therethrough an IOL 3406and/or other devices to be positioned in the housing structure 3402. Insome implementations, the housing structure 3402 is configured to havean hourglass configuration such that the prosthetic device 3400comprises arced or almond-shaped cutout portions 3408, 3410. Theprosthetic device 3400 can be advantageous because the hourglass shapeof the housing structure 3402 can allow for the distal portions 3412A,3412B of the haptics 3414A, 3414B, respectively, of an IOL 3406 to bemoved to various positions within the housing structure 3402. Forexample, the IOL 3406 can be rotated counterclockwise until the distaltips 3412A, 3412B of the haptics 3414A, 3414B, respectively, touch thearc edge portions 3416A, 3416B, respectively. The IOL 3406 can beinhibited or prevented from rotating clockwise, providing rotationalcertainty. Alternatively, the IOL 3406 could be rotated clockwise intoanother (e.g., opposite) position. The IOL 3406 may be rotateddifferently if the haptics 3414A, 3414B are shaped differently.

By providing rotational flexibility and certainty for the IOL 3406positioned in the housing 3402, the surgeon or other user can betterposition the IOL 3406 in the eye to achieve good or best performance orresults for the patient. With reference to FIG. 35, the prostheticdevice 3500 can provide similar rotational flexibility as disclosed forthe prosthetic device 3400. In some implementations, the prostheticdevice 3500 comprises a housing structure 3502 that is coupled to a ringstructure 3504. The housing structure 3502 can comprise wing portions3508, 3510. In some implementations, the wing portions 3508, 3510 areconfigured to receive the distal portions 3512A, 3512B of the haptics3506, 3507, respectively, of an IOL 3506. The wing portions 3508, 3510may include a bulbous end (e.g., as illustrated in FIG. 35), may taperto a point or a blunt end, or have any other shape suitable forinteracting with the haptics 3506, 3507. The surgeon or other user canrotate the IOL 3506 in a counterclockwise direction, for example untilthe haptics 3506, 3507 engage or interact with the wing portions 3508,3510, in order to better position the IOL 3506 within the eye to achievegood or best performance or results for the patient. In an embodiment,the wing portions 3508, 3510 may also be designed to engage the housingstructure 3502 more proximally, substantially decreasing the volume ofthe prosthetic device 3500. In an embodiment, the prosthetic device canbe form fitted to the IOL. This configuration of the prosthetic devicecan be limited in application to a prosthetic device 3500 capable ofsimply housing another IOL 3506 without the ability to rotate said IOL3506 or haptics 3506, 3507, or distal portions 3512A, 3512B within saidprosthetic device 3500 or to contain much additional technology. In anembodiment, the peripheral outline of such a device can be configured tosubstantially follow the shape of a traditional IOL 3506. Additionally,the ring structure may or may not be present in such an implementation.

FIG. 36 illustrates a prosthetic device 3600 comprising a housingstructure 3601 that is coupled to a ring structure 3603. In someimplementations, the housing structure 3601 comprises an opening in theposterior portion 3606 of the housing structure 3601. In someimplementations, the posterior portion 3606 of the housing structure canbe configured to receive a lens structure 3602. As described herein, thelens structure 3602 can serve as a refractive lens that provides areference point for the surgeon or other user to select an appropriateIOL and to position the IOL in the housing structure 3601 to achievegood or best performance or results for the patient. In someimplementations, the housing structure 3601 comprises a second openingin the anterior portion 3608 of the housing structure 3601. As describedherein, the second opening in the anterior portion 3608 can beconfigured to receive therethrough an IOL 3604 and/or other devices tobe positioned in the housing structure 3601.

The prosthetic device 3600 can be advantageous because, by including aseparate lens structure, the prosthetic device 3600, more specificallythe housing structure 3601, can have a reduced mass versus devicescomprising an integral or coupled refractive posterior portion. Withless mass in the housing structure 3601, the prosthetic device 3600 canbe rolled up or folded in a more compact fashion for positioning into aninsertion tool. A surgeon or other user may be able to utilize a smallerinsertion tool that uses a smaller incision. The surgeon or other usercan couple the prosthetic device 3600 to the lens 3602 while eachcomponent is in the natural capsular bag, for example after beingdelivered through an incision in series. After the components haveexpanded (e.g., self-expanded) into their expanded states, the surgeonor user can position the lens 3602 into the opening of the posteriorportion 3606. The surgeon may create a posterior capsulorhexis whilestill supporting the housing structure 3601 (e.g., in combination with aring structure 3603) and the posterior segment 3602, which could enhancethe ease or reduce the difficulty of performing a procedure forinserting the device 3600 through manual means, and can inhibit orprevent vitreous prolapse. The device 3600 may be used in conjunctionwith a femtosecond laser to create the posterior capsulorhexis. Afterthe posterior capsulorhexis is created, the posterior capsular materialcan be removed from the eye, which can inhibit or prevent (e.g.,forever) development of a posterior capsular opacification, and whichcan possibly inhibit or prevent long term shifts in IOL position throughcapsular contraction. Before or after the housing structure 3601 isinserted, the lens 3602 of the prosthetic capsular device 3600 could beinserted.

In some implementations, the lens 3602 can be configured to be coupledto the opening in the posterior portion 3606 using a friction fit. Insome implementations, the lens 3602 is coupled to the opening in theposterior portion 3606 through sutures or other mechanisms for attachingthe lens 3602 to the posterior portion 3606. As described in otherexamples herein, the prosthetic device 3600 can comprise an opening inthe anterior portion 3608 of the housing structure 3601. In someimplementations, the opening in the anterior portion 3608 can beconfigured to receive therethrough an IOL 3604 and/or other devices forpositioning in the housing structure 3601.

FIGS. 37A and 37B illustrate an example of a prosthetic device 3700. Theprosthetic device 3700 comprises a housing structure 3701 comprising aplurality of tabs 3703. In some implementations, the housing structure3701 comprises an opening 3704 in the posterior portion of the housingstructure 3701 for receiving a separate lens 3702. In someimplementations, the housing structure 3701 comprises an opening 3706 inthe anterior portion 3708 of the housing structure 3701. In someimplementations, the opening 3706 in the anterior portion 3708 can beconfigured to receive therethrough an IOL and/or other devices forpositioning in the housing structure 3701.

FIGS. 38A-38B illustrate an example of a prosthetic device 3800. Theprosthetic device 3800 comprises a housing structure 3801 that iscoupled to a ring structure 3803A, 3803B. In some implementations, thehousing structure 3801 comprises an opening 3804 in the posteriorportion 3808 of the housing structure 3801. In some implementations, theopening 3804 is configured to receive a lens structure 3802. In someimplementations, the housing structure 3801 comprises an opening 3806 inthe anterior portion 3810 of the housing structure 3801. In someimplementations, the opening 3806 can be configured to receivetherethrough an IOL and/or other devices for positioning in the housingstructure 3801.

In some implementations of a multi-component prosthetic capsular deviceassembly comprising a separate posterior optic, the posterior optic maybe coupled to a housing structure without a posterior optic (e.g.,instead comprising a posterior opening, a non-refractively poweredmembrane, or a refractively powered optic configured to provide partialrefractive power). For example, the housing structure may include one ormore openings or slits and the posterior optic can include a post havinga lip, vice versa, or combinations thereof. In some implementations, apattern of openings and posts can be a proprietary lock and keyconfiguration, for example to ensure quality control. The posterioroptic can be inserted separately from (e.g., before or after) thehousing structure, which could reduce material volume during eachinjection, reducing incision size. When the post is inserted through anopening, the lip can inhibit or prevent the posterior optic fromuncoupling from the housing structure. If desired, the posterior opticcan be exchanged, for example by forcing the lip through the opening,which can allow flexibility for a variety of potentially desired optics(e.g., multifocal, toric, higher power, lower power, etc.). In someimplementations, the pattern can include threads (e.g., external threadson the optic and internal threads on the opening, or vice versa) havinga particular winding density, helical width, etc.

FIG. 39 illustrates an example of a prosthetic device 3900. In someimplementations, the prosthetic device 3900 comprises a substantiallyplanar housing structure 3901 that is coupled to a ring structure 3903(e.g., comprising a polyimide loop structure). The ring structure 3903may include features described herein (e.g., arcuate or sinusoidalshape, coupling or anchoring to the housing structure 3901). In someimplementations, the substantially planar housing structure 3901comprises a refractive portion 3904. Unlike other examples disclosedherein, the prosthetic device 3900 is not configured to receive an IOLand/or other devices for positioning in the substantially planar housingstructure 3901. Rather, the substantially planar housing structure 3901is configured to retain the refractive portion 3904 within the naturalcapsular bag 1318.

Similar to the posterior refractive portion of the housing structureswithin the prosthetic devices described herein, the refractive portion3904 can be used by a surgeon or other user as a point of reference indetermining or selecting an IOL 3902 for implantation in the naturalcapsular bag 1318. The prosthetic device 3900 can be advantageousbecause without a three-dimensional housing structure, further mass andmaterial can be removed from the prosthetic device 3900. With additionalmass and material removed from the prosthetic device 3900, the devicecan be rolled up or folded in a more compact fashion for insertion intothe insertion tool. With a more compact folded configuration, thesurgeon can utilize a insertion tool with a smaller diameter and canmake a smaller incision in the eye. The housing structure 3901 may stillprovide other advantages described herein such as providing a barrier tocontact with the vitreous humor, housing electronics and otherstructures, etc.

FIG. 40 illustrates an example of a prosthetic device 4000. The device4000 may be substantially similar in composition to a capsular tensionring. The prosthetic device 4000 comprises a wire frame 4004. The wireframe 4004 comprise or can be made of a single material or combinationof materials that are biocompatible within the eye, including, but notlimited to, PMMA, acrylic, silicone, collamer, nitinol, nylon,polypropylene, polyimide, PTFE, polyester, combinations thereof, and thelike. In some implementations, the wire frame 4004 comprises a curled upshape configured to encircle the natural capsular bag 1318 multipletimes, which can create volumetric separation of the anterior andposterior capsules while providing stability to the capsular bag ininstances where zonules may be weak, torn, damaged and/or absent. Insome implementations, the wire frame 4004 is configured to expand in thenatural capsular bag 1318 to mechanically expand and/or maintain thesize of the natural capsular bag 1318. In some implementations, theprosthetic device 4000 is configured to receive an IOL 4002 and/or otherdevices for implantation in the natural capsular bag 1318. In someimplementations, the wire frame 4004 of the prosthetic device 4000 iscurled in a fashion so as to not interfere with the optical path. Insome implementations, the lack of a housing structure of the prostheticdevice 4000 may advantageously allow mass and material to be omittedfrom the prosthetic device 4000. With less mass and material, theprosthetic device 4000 can be more compactly rolled up or folded into aninsertion tool. Having a more compact form can allow the surgeon toutilize an insertion tool having a smaller diameter and/or can allow thesurgeon or other user to make a smaller incision in the eye. Theprosthetic device 4000 may still provide other advantages describedherein such as providing a barrier to contact with the vitreous humor,housing electronics and other structures, etc. In some implementations,the prosthetic device 4000 comprises a refractive surface.

FIG. 41 illustrates an example of a prosthetic device 4100. Theprosthetic device 4100 comprises a housing structure 4102 that iscoupled to an outer ring structure 4104 and an inner ring structure4106. In some implementations, the outer ring structure 4104 isconfigured to be positioned in the sulcus 1322A, 1322B of the eye (e.g.,as described herein with respect to the flange 20). In someimplementations, the inner ring structure 4106 is configured to bepositioned in the natural capsular bag 1318. In some implementations,the prosthetic device 4100 can be advantageous because by positioningthe outer ring structure 4104 in the sulcus 1322A, 1322B, the housingstructure 4102 can be securely positioned in the natural capsular bag1318. In some implementations, the outer ring structure 4104 can beconfigured to inhibit or prevent the housing structure 4102 of theprosthetic device 4100 from migrating in or out of the natural capsularbag 1318. By maintaining the position of the housing structure 4102, theprosthetic device 4100 can be maintained in the eye at a fixed positioneven as the eye changes over time. In some implementations, the innerring structure 4106 can be configured to mechanically expand and/ormaintain the natural volume of the natural capsular bag 1318. In someimplementations, the housing structure 4102 can be configured to receivethrough an opening in an anterior surface an IOL 4108 and/or otherdevices for positioning in the housing structure 4102.

FIG. 42 illustrates an example of a prosthetic device 4200. Theprosthetic device 4200 comprises a housing portion 4201 that is coupledto one or more ring structures 4203. In some implementations, thehousing structure 4201 comprises an anterior portion 4204. Unlike inother examples disclosed herein, the anterior portion 4204 does notcomprise an opening but rather comprises a refractive portion. In someimplementations, the housing portion 4201 comprises a posterior portion4208. Unlike in other examples disclosed herein, the posterior portion4208 does not comprise a refractive portion but rather comprises anopening for receiving an IOL 4206 and/or other devices for positioningin the housing structure 4201. In some implementations, the prostheticdevice 4200 can be advantageous because the prosthetic device 4200 canbe combined with an IOL 4202 to act like a telescope or an apparatus formagnifying the visibility of objects. In order to produce themagnification of objects, the prosthetic device 4200 is utilized tocreate space between the IOL 4202 and the refractive portion in theanterior portion 4204 and/or the IOL 4206 positioned within the housingstructure 4201.

FIG. 43A illustrates an anterior side perspective view of an example ofa prosthetic capsular device 4300. The device 4300 comprises an anteriorside 4302, a posterior side 4304, and sidewalls 4306 extending betweenthe anterior side 4302 and the posterior side 4304. The anterior side4302 comprises an opening 4308. The posterior side 4304 optionallycomprises a refractive surface 4310. In some implementations, theprosthetic device 4300 comprises a ring structure 4320 coupled to ahousing structure 4312 comprising the anterior side 4302, posterior side4304, and sidewalls 4306. In some implementations, the ring structure4320 comprises a material that is sufficiently strong to maintain thecircumference of a natural capsular bag. In some implementations, thering structure 4320 is configured to be sufficiently flexible to adjustand conform to the natural shape of a natural capsular bag, which can beasymmetrical. In some implementations, the ring structure 4320 isconfigured to secure the prosthetic device 4300 within the naturalcapsular bag or other eye region through a friction fit. For example,the ring structure 4320 can comprise polyimide, materials known inintraocular lens manufacturing such as silicone, collamer, PMMA,acrylic, and acrylates, materials used in permanent suture applicationssuch as polypropylene, nylon, polytetrafluoroethylene (PTFE), andpolyester, shape memory or thermal memory materials such as nitinol,chromium cobalt, and shape memory polymers, combinations thereof, andthe like. In some implementations, the ring structure 4320 compriseshydrophilic and/or hydrophobic materials.

In some implementations, the ring structure 4320 comprises at least tworing portions 4320A, 4320B. Like the device 2100 in which the ringstructure 2106 is embedded across an entire length of a portion of thehousing structure 2102, the ring structure 4320 is embedded in at leasta portion of the housing structure 4312 by anchors 4320C, 4320D. Theanchors 4320C, 4320D comprise a first portion 4322A that extends betweenthe ring portions 4320A, 4320B and a second portion 4322B that extendsalong side portions of the housing structure 4312. The first portion4322A and the second portion 4322B may comprise the same or similarproperties or at least one property that is different (e.g., material,composition, dimension, cross-sectional shape, combinations thereof,etc.). The anchors 4320C, 4320D and the ring portions 4320A, 4320B maycomprise the same or similar properties or at least one property that isdifferent (e.g., material, composition, dimension, cross-sectionalshape, combinations thereof, etc.). As discussed as an optional variantof FIG. 22B, the longitudinal anchors 4322B extend partially along alength of the side portions of the housing structure 4312. Referring toFIG. 43B, the distance 4330 the anchor portions 4322B are spaced alongthe major axis is between about 2 mm and about 4 mm (e.g., about 2 mm,about 2.5 mm, about 3 mm, about 3.5 mm, about 4 mm, ranges between suchvalues, etc.). The longitudinal anchors 4322B could extend along theentire length of the side portions of the housing structure 4312, alongthe side portions by different amounts, change direction, etc.

The ring structure 4320 comprises an undulating or sinusoidal shapeincluding alternating radially inward troughs 4324 and radially outwardpeaks or apices 4326. As described with respect to FIGS. 19-22C, a ringstructure 4320 having a sinusoidal shape can flex and conform to theshape of the natural capsular bag, which can provide improvedpositioning within an irregular natural capsular bag shape. In certainimplementations, the tip or apex radially outward portions 4327 of thesinusoidal wave are configured to engage the natural capsular bag. Asdiscussed as an optional variant of FIGS. 19-22C, the shape of thesinusoidal ring structure 4320 comprises some apices 4326 having alarger diameter than other apices 4326. In certain implementations, aring structure having a substantially circular or oval or ellipticalconfiguration may not be able to conform to an irregular and/orasymmetrical shape of a natural capsular bag as well as a ring structurehaving a sinusoidal shape.

The ring portions 4320A, 4320B comprise holes or apertures or openingsor eyelets 4328. The openings 4328 may be used, for example, to suturethe device 4300 to an eye. The openings 4328 illustrated in FIGS. 43Aand 43B extend all of the way through the ring structure 4320, but couldextend only partially through the ring structure 4320. The openings 4328may assist in suturing the device 4300, allow fibrosis therethrough,etc. The ring structure 4320 may comprise more or fewer openings 4328,openings 4328 at different locations (e.g., at troughs 4324, at otherapices 4326), etc. The openings 4328 may be formed, for example, byphoto-etching and/or laser milling polyimide.

FIG. 43B illustrates an anterior plan view of the example prostheticcapsular device 4300 of FIG. 43A. The prosthetic capsular device 4300has a major axis along the line 43C-43C and a minor axis along the line43D-43D. FIG. 43C illustrates a cross-sectional view of the exampleprosthetic capsular device 4300 of FIG. 43A along the line 43C-43C ofFIG. 43B. FIG. 43D illustrates a cross-sectional view of the exampleprosthetic capsular device 4300 of FIG. 43A along the line 43D-43D ofFIG. 43B.

FIGS. 43B-43D illustrate example dimensions of the device 4300. Theouter or under certain circumstances maximum diameter 4350 of the device4300 may be between about 9 mm and about 11 mm (e.g., about 9 mm, about9.5 mm, about 10 mm, about 10.5 mm, about 11 mm, ranges between suchvalues, etc.). The length 4352 of the opening 4308 in the anterior side4302 along the major axis may be between about 7 mm and about 8 mm(e.g., about 7 mm, about 7.5 mm, about 8 mm, ranges between such values,etc.). The length 4354 of the opening 4308 in the anterior side 4302along the minor axis may be between about 6 mm and about 7 mm (e.g.,about 6 mm, about 6.5 mm, about 7 mm, ranges between such values, etc.).The opening 4308 illustrated in FIGS. 43A-43D is oblong, with the length4352 being greater than the length 4354, but is not as oblong as thehousing structure 4312. In some implementations, the opening 4308 may becircular, more oblong, less oblong, and/or include straight portions.The diameter of the refractive surface 4310 of the posterior side 4304may be between about 4 mm and about 6 mm (e.g., about 4 mm, about 4.5mm, about 5 mm, about 5.5 mm, about 6 mm, ranges between such values,etc.).

The distance 4356 between the openings 4328 of the ring portion 4320Aand the openings 4328 of the ring portion 4320B along the minor axis maybe between about 7 mm and about 8 mm (e.g., about 7 mm, about 7.25 mm,about 7.5 mm, about 7.75 mm, about 8 mm, ranges between such values,etc.). The distance 4358 between the openings 4328 of the ring portion4320A and the openings 4328 of the ring portion 4320B along the majoraxis may be between about 4 mm and about 5 mm (e.g., about 4 mm, about4.25 mm, about 4.5 mm, about 4.75 mm, about 5 mm, ranges between suchvalues, etc.). The dimensions described herein can affect position ofthe device 4300 with respect to the circumference of the scleral wall.For example, if the holes 4328 are used to suture the device 4300 to thescleral wall, the holes 4328 are preferably spaced or far enough awayfrom each other to provide stable anchor points that are preferablysymmetrical.

As the device 4300 is folded along the major axis for insertion in aneye, the refractive surface 4310 can stretch along the minor axis. Insome implementations, the refractive surface 4310 can stretch at leastabout 110%, about 120%, about 130%, about 140%, about 150%, about 160%,about 170%, about 180%, about 190%, about 200%, or more. In someimplementations, the refractive surface 4310 can stretch between about110% and about 600% (e.g., about 110%, about 120%, about 130%, about140%, about 150%, about 160%, about 170%, about 180%, about 190%, about200%, about 250%, about 300%, about 350%, about 400%, about 450%, about500%, about 550%, about 600%, ranges between such values, less thanabout 110% (e.g., between about 0% and about 110%), greater than about200%, greater than about 300%, greater than about 400%, greater thanabout 500%, greater than about 600%, etc.). As the devices 4300 isunfolded (e.g., self-expands), the ring structure 4320 can also stretchdue to straightening of the undulations. The length of an arc betweenthe attachment points between the ring portions 4320A, 4320B shown bythe dotted line 4360 is about 7.7 mm. The length of the outer edge ofeach ring portion 4320A, 4320B is about 10.46 mm. The ring portions4320A, 4320B can stretch along the major axis to a length greater thanthe housing structure arc, reducing the danger that the ring structure4320 may be pulled out of the housing structure 4312.

The radius of curvature of a refractive portion 4310 having a diameterof 5 mm is between about 6.39 mm for a 30 diopter equi-convex lens. Theradius of curvature may be different for larger or smaller diopters, arefractive portion 4310 with a different diameter, a non-equiconvexlens, etc. The thickness of a wall of the posterior side 4304 radiallyoutward of the refractive surface 4310 and the sidewalls 4306 may bebetween about 0.1 mm and about 0.4 mm (e.g., about 0.1 mm, about 0.15mm, about 0.2 mm, about 0.25 mm, about 0.3 mm, about 0.35 mm, about 0.4mm, ranges between such values, etc.). In some implementations, thesidewalls 4306 may be thicker or thinner than the posterior wall. Thethickness 4366 of the device 4300 between the anterior side 4302 and theposterior side 4304 may be between about 2 mm and about 3 mm (e.g.,about 2 mm, about 2.25 mm, about 2.5 mm, about 2.75 mm, about 3 mm,ranges between such values, etc.). The thicknesses 4368, 4370 betweeninflection points or design features and the posterior side 4304 may beless than the thickness 4366 because they are closer to the posteriorside 4304. For example, the anterior side 4302 may comprise a lip 4314having a thickness 4374 of about 0.2 mm such that the thickness 4366 maybe about 0.2 mm greater than the thickness 4368. Other lip 4314thicknesses 4374 are also possible, for example being the same as ordifferent than wall and/or sidewall thicknesses. For another example,the anterior side 4302 may comprise a radially inward taper, and thethickness 4370 between the start of the taper (e.g., where the sidewalls4306 are generally parallel to a longitudinal axis of the device 4300)and the lip 4314 may be about 0.25 mm such that the thickness 4366 maybe about 0.45 mm greater than the thickness 4368. The thickness 4372between the end of the refractive surface 4310 and the anterior side4304 may be greater than the thickness 4366 because the refractivesurface 4310 extends outwardly of the wall of the posterior side 4304.For example, the refractive surface 4310 may protrude about 0.509 mmsuch that the thickness 4372 may be about 0.509 mm greater than thethickness 4366, and may vary by diopter value, lens type, lens diameter,etc.

The ring structure 4320 may have a thickness 4376 between about 0.1 mmand about 0.15 mm (e.g., about 0.1 mm, about 0.11 mm, about 0.12 mm,about 0.125 mm, about 0.13 mm, about 0.14 mm, about 0.15 mm, rangesbetween such values, etc.). A distance between the ring structure 4320,for example measured at an approximate midpoint, and the posterior side4304 may be between about 0.25 mm and about 2.5 mm (e.g., about 0.25 mm,about 0.5 mm, about 0.75 mm, about 1 mm, about 1.25 mm, about 1.5 mm,about 1.75 mm, about 2 mm, about 2.5 mm, ranges between such values,etc.). The longitudinal position of the ring structure 4320 may be moreproximate to the anterior side 4302 or the posterior side 4304, forexample based on expected interaction with a natural capsular bag.

FIG. 43E illustrates an anterior side perspective view of an example ofa prosthetic capsular device system 4399. FIG. 43F illustrates ananterior plan view of the example prosthetic capsular device system 4399of FIG. 43E. FIG. 43G illustrates a cross-sectional view of the exampleprosthetic capsular device system 4399 of FIG. 43E along the line43G-43G of FIG. 43F. FIG. 43H illustrates a side view of the exampleprosthetic capsular device system 4399 of FIG. 43E. The system 4399comprises a prosthetic capsular device 4301 and an intraocular lens4371.

The intraocular lens 4371 comprises haptics 4373 extending radiallyoutward from a refractive portion 4375. The haptics 4373 then turngenerally coaxial with the refractive portion 4375 to be radiallyoutward of and spaced from the refractive portion 4375. The system 4399may comprise other types of intraocular lenses 4371 including, but notlimited to: spherical, aspheric, wavefront, convex, concave, multifocal(diffractive, refractive, zonal), toric, accommodative, ultraviolet (UV)filtering, diffractive chromatic aberration reducing lenses, and lightadjustable lenses (ultraviolet light adjustable, femtosecond phasewrapping), with optical powers ranging from any positive diopter value(e.g., including +35 D and above) to any negative diopter value (e.g.,including −35 D and below), and including any prism power (including 60Prism Diopters and above). The system 4399 may include a component of anoptical system designed to work in conjunction with the refractive lensof the prosthetic capsular device, which can create a polypseudophakicoptical system such as a telescope, or provide modification of multiplerefractive qualities (e.g. astigmatism, spherical aberration, extendeddepth of focus, and/or multifocality).

The prosthetic capsular device 4301 has a major axis along the line43G-43G and a minor axis orthogonal to the line 43G-43G. The device 4301comprises an anterior side 4303, a posterior side 4305, and sidewalls4307 extending between the anterior side 4303 and the posterior side4305. The anterior side 4303 comprises an opening 4309. The posteriorside 4305 optionally comprises a refractive surface 4311. In someimplementations, the prosthetic device 4301 comprises a ring structure4321 coupled to a housing structure 4313 comprising the anterior side4303, posterior side 4305, and sidewalls 4307. The intraocular device4371 abuts interior surfaces 4379 of the sidewalls 4307. The device 4301is devoid of or lacks an interior lip.

The sidewalls 4307 have an outer surface 4377 and an inner surface 4379.Like the sidewalls of the devices 400, 1000, 1100, 1150, 1250, 2250,2300, 2900, 3100, 4300, for example, the sidewalls 4307 include a firststraight-walled portion extending anteriorly from the posterior surface4305 and a second part that tapers radially-inwardly toward the opening4309 of the anterior surface 4303. The first and second parts may beidentified by a transition point 4381, or may be identified based on theproperties (e.g., shape, function, etc.) of the parts. Thestraight-walled portion of the sidewalls 4307 may be parallel orsubstantially parallel with a longitudinal axis of the device 4301. Thestraight-walled portion of the sidewalls 4307 may be orthogonal orsubstantially orthogonal to a flat portion of the posterior surface ofthe device 4301. The straight-walled portion of the sidewalls 4307 maybe orthogonal or substantially orthogonal to the opening 4309. Thestraight-walled portion of the sidewalls 4307 can increase space in thecavity of the device 4301. The space can be used for intraocular lenses,other optical devices, drug eluting devices, electronic devices, and thelike. The device 4301 provides a platform for insertion, and evenremoval, of various articles into an eye.

In some implementations, a prosthetic capsular device comprising convexor dual-tapered sidewalls (e.g., as in the devices 10, 110, 210, 900)includes an interior lip configured to inhibit or prevent anteriormovement of the IOL. In some embodiments, the interior lip is proximateto the posterior end of the device. In some embodiments, the device maybe configured to interact with a particular type of IOL, type ofhaptics, and/or IOL diopter value.

In some implementations, the ring structure 4321 comprises a materialthat is sufficiently strong to maintain the circumference of a naturalcapsular bag. In some implementations, the ring structure 4321 isconfigured to be sufficiently flexible to adjust and conform to thenatural shape of a natural capsular bag, which can be asymmetrical. Insome implementations, the ring structure 4321 is configured to securethe prosthetic device 4301 within the natural capsular bag or other eyeregion through a friction fit. For example, the ring structure 4321 cancomprise polyimide, materials known in intraocular lens manufacturingsuch as silicone, collamer, PMMA, acrylic, and acrylates, materials usedin permanent suture applications such as polypropylene, nylon,polytetrafluoroethylene (PTFE), and polyester, shape memory or thermalmemory materials such as nitinol, chromium cobalt, and shape memorypolymers, combinations thereof, and the like. In some implementations,the ring structure 4321 comprises hydrophilic and/or hydrophobicmaterials.

In some implementations, the ring structure 4321 comprises ring portions4321A, 4321B. Other numbers of ring portions are also possible, (e.g.,one, three, four, etc.). The ring structure 4321 is embedded in at leasta portion of the housing structure 4313 by anchors 4321C, 4321D. Theanchors 4321C, 4321D comprise a first portion 4323A that extends betweenthe ring portions 4321A, 4321B and a second portion 4323B that extendalong side portions of the housing structure 4313. The first portion4323A and the second portion 4323B may comprise the same or similarproperties or at least one property that is different (e.g., material,composition, dimension, cross-sectional shape, combinations thereof,etc.). The anchors 4321C, 4321D and the ring portions 4321A, 4321B maycomprise the same or similar properties or at least one property that isdifferent (e.g., material, composition, dimension, cross-sectionalshape, combinations thereof, etc.). As discussed as an optional variantof FIG. 22B and as discussed with respect to FIG. 43A, the longitudinalanchors 4323B extend partially along a length of the side portions ofthe housing structure 4313. The longitudinal anchors 4323B could extendalong the entire length of the side portions of the housing structure4313, along the side portions by different amounts, change direction,etc.

The ring structure 4321 comprises an undulating or sinusoidal shapeincluding alternating radially inward troughs 4325 and radially outwardpeaks or apices 4327. As described with respect to FIGS. 19-22C and43A-43D, a ring structure 4321 having a sinusoidal shape can flex andconform to the shape of the natural capsular bag, which can provideimproved positioning within an irregular natural capsular bag shape. Incertain implementations, the tip or apex radially outward portions 4327of the sinusoidal wave are configured to engage the natural capsularbag. The shape of the sinusoidal ring structure 4321 comprises someapices 4327 having a larger diameter than other apices 4327. In certainimplementations, a ring structure having a substantially circular oroval or elliptical configuration may not be able to conform to anirregular and/or asymmetrical shape of a natural capsular bag as well asa ring structure having a sinusoidal shape.

The ring portions 4321A, 4321B comprise holes or apertures or openingsor eyelets 4329. The openings 4329 may be used, for example, to suturethe device 4301 to an eye. The openings 4329 illustrated in FIGS. 43Eand 43F extend all of the way through the ring structure 4321, but couldextend only partially through the ring structure 4321. The openings 4329may assist in suturing the device 4301, allow fibrosis therethrough,etc. The ring structure 4321 may comprise more or fewer openings 4329,openings 4329 at different locations (e.g., at troughs 4325, at otherapices 4327), etc. The openings 4329 may be formed, for example, byphoto-etching and/or laser milling polyimide.

Example dimensions of the device 4301, some of which are provided below,may be the same or similar to the example dimensions of the device 4300,modifications thereof, and/or other devices described herein. The outeror under certain circumstances maximum diameter 4351 of the device 4301may be between about 9 mm and about 11 mm (e.g., about 9 mm, about 9.5mm, about 10 mm, about 10.5 mm, about 11 mm, ranges between such values,etc.). The length of the opening 4309 in the anterior side 4303 alongthe major axis may be between about 7 mm and about 8 mm (e.g., about 7mm, about 7.5 mm, about 8 mm, ranges between such values, etc.). Thelength of the opening 4309 in the anterior side 4303 along the minoraxis may be between about 6 mm and about 7 mm (e.g., about 6 mm, about6.5 mm, about 7 mm, ranges between such values, etc.). The opening 4309may be oblong (e.g., longer along the major axis), circular, and/orother shapes. The diameter of the refractive surface 4311 of theposterior side 4305 may be between about 4 mm and about 6 mm (e.g.,about 4 mm, about 4.5 mm, about 5 mm, about 5.5 mm, about 6 mm, rangesbetween such values, etc.).

The distance between the openings of the ring portion 4321A and theopenings 4329 of the ring portion 4321B along the minor axis may bebetween about 7 mm and about 8 mm (e.g., about 7 mm, about 7.25 mm,about 7.5 mm, about 7.75 mm, about 8 mm, ranges between such values,etc.). The distance between the openings 4329 of the ring portion 4321Aand the openings 4329 of the ring portion 4321B along the major axis maybe between about 4 mm and about 5 mm (e.g., about 4 mm, about 4.25 mm,about 4.5 mm, about 4.75 mm, about 5 mm, ranges between such values,etc.). The dimensions described herein can affect position of the device4301 with respect to the circumference of the scleral wall. For example,if the holes 4329 are used to suture the device 4301 to the scleralwall, the holes 4329 are preferably spaced or far enough away from eachother to provide stable anchor points that are preferably symmetrical.

As the device 4301 is folded along the major axis for insertion in aneye, the refractive surface 4311 can stretch along the minor axis. Insome implementations, the refractive surface 4311 can stretch at leastabout 110%, about 120%, about 130%, about 140%, about 150%, about 160%,about 170%, about 180%, about 190%, about 200%, or more. In someimplementations, the refractive surface 4311 can stretch between about110% and about 600% (e.g., about 110%, about 120%, about 130%, about140%, about 150%, about 160%, about 170%, about 180%, about 190%, about200%, about 250%, about 300%, about 350%, about 400%, about 450%, about500%, about 550%, about 600%, ranges between such values, less thanabout 110% (e.g., between about 0% and about 110%), greater than about200%, greater than about 300%, greater than about 400%, greater thanabout 500%, greater than about 600%, etc.). As the devices 4301 isunfolded (e.g., self-expands), the ring structure 4321 can also stretchdue to straightening of the undulations. The ring portions 4321A, 4321Bcan stretch along the major axis to a length greater than the housingstructure arc, reducing the danger that the ring structure 4321 may bepulled out of the housing structure 4313.

The thickness of a wall of the posterior side 4305 radially outward ofthe refractive surface 4311 and the sidewalls 4307 may be between about0.1 mm and about 0.4 mm (e.g., about 0.1 mm, about 0.15 mm, about 0.2mm, about 0.25 mm, about 0.3 mm, about 0.35 mm, about 0.4 mm, rangesbetween such values, etc.). In some implementations, the sidewalls 4307may be thicker or thinner than the posterior wall. The thickness of thedevice 4301 between the anterior side 4303 and the posterior side 4305may be between about 2 mm and about 3 mm (e.g., about 2 mm, about 2.25mm, about 2.5 mm, about 2.75 mm, about 3 mm, ranges between such values,etc.).

The ring structure 4321 may have a thickness between about 0.1 mm andabout 0.15 mm (e.g., about 0.1 mm, about 0.11 mm, about 0.12 mm, about0.125 mm, about 0.13 mm, about 0.14 mm, about 0.15 mm, ranges betweensuch values, etc.). A distance between the ring structure 4321, forexample measured at an approximate midpoint, and the posterior side 4305may be between about 0.25 mm and about 2.5 mm (e.g., about 0.25 mm,about 0.5 mm, about 0.75 mm, about 1 mm, about 1.25 mm, about 1.5 mm,about 1.75 mm, about 2 mm, about 2.5 mm, ranges between such values,etc.). The longitudinal position of the ring structure 4321 may be moreproximate to the anterior side 4303 or the posterior side 4305, forexample based on expected interaction with a natural capsular bag.

FIG. 57A is an exploded perspective view of an example kit 5700including a prosthetic capsular device 4301. FIG. 57B is a top plan viewof the example kit of FIG. 57A. FIG. 57C illustrates a cross-sectionalview of the example kit of FIG. 57A along the line 57C-57C of FIG. 57B.FIG. 57D illustrates a cross-sectional view of the example kit of FIG.57A along the line 57D-57D of FIG. 57B. FIG. 57E illustrates across-sectional view of the example kit of FIG. 57A along the line57E-57E of FIG. 57B. Although illustrated and described herein withrespect to the device 4301, the kit 5700 may comprise any of the devicesdescribed herein, other prosthetic devices, intraocular lenses, othertypes of implants, fluids, instruments, and the like. The kit includes acase 5702 and a lid 5704.

FIG. 57F is a top plan view of a component, the base 5702, of theexample kit 5700 of FIG. 57A holding a device 4301. The case 5702comprises rounded rectangular shape. In some implementations, the case5702 comprises a shape corresponding to or reminiscent of the device4301 (e.g., without the ring structure 4321).

The case 5702 comprises a cavity 5706. The cavity 5706, which can beseen in the cross-sections of FIGS. 57C-57E, can reduce weight, reducematerial usage to save costs, provide stacking interlock, provide grip,and/or provide other possible advantages.

An upper surface of the case 5702 identification indicia 5708. Theindicia 5708 can include information about the device 4301, such asdiopter value, serial number, outer diameter, refractive surfacediameter, thickness manufacturer, shape, material, etc.). The indicia5708 may be grouped together, placed around the device 4301, ondifferent surfaces of the case 5702, on the lid 5704, etc.

The case 5702 comprises a lid engagement structure extending from theupper surface. The lid engagement structure comprises a first part 5710and a second part 5711. The first part 5710 is spaced from the secondpart 5711 by a gap 5712. Each of the first part 5710 and the second part5711 comprises a plurality of frustoconical posts 5714. As best seen inFIG. 57B, the posts 5714 can help to securely hold the device 4301. Moreor fewer posts or other shapes (e.g., arcs) may be used. The posts maybe configured to be interact with the housing 4313 (e.g., as illustratedin FIG. 57B), the ring structure 4321, the openings 4329, and/or otherparts of the device 4301 and/or other devices. For example, in the outerdiameter of the device 4301 is 10 mm, the inner edges of the posts 5714may be slightly greater than 10 mm (e.g., about 10.01 mm to about 11mm).

As best seen in FIG. 57E, each of the first part 5710 and the secondpart 5711 comprises a C-shaped or (-shaped upwardly projecting wallincluding a cutout 5716 forming an outwardly projecting lip 5718. Thelid 5704 comprises a plurality of teeth 5720 each including an inwardlyprojecting lip 5722. The lips 5722 are configured to interact with thelips 5718 to secure the lid 5704 to the base 5702 by positioning the lid5704 with the lips 5722 in the gap 5712 and rotating clockwise until thelips 5722 are under the lips 5718. The teeth 5720 may provide radialflexibility to the lip 5722 and/or identification of the location of thelip 5722. In some implementations, the lid 5704 is devoid of the teeth5720 but includes the lips 5722. The base 5702 may comprise cutouts 5716on other segments of the parts 5710, 5711, for example to allowinterlocking of the lid 5704 to the base 5702 by turning in acounterclockwise direction.

The lid 5704 comprises a hollow generally round body including aplurality of outwardly projecting tabs 5724. The tabs 5724 may provide agripping surface. More or fewer tabs 5724 and/or tabs 5724 having adifferent shape can be used. The tabs 5724 may correspond to a shape onthe base 5702, for example to indicate a locked state. In someimplementations, the lid 5704 is devoid of tabs 5724. In certain suchembodiments, the lid 5704 may comprise a roughened edge surface. In someimplementations, the lid 5704 is comprises a shape corresponding to thedevice 4301, for example an outer edge of the device 4301, with orwithout the ring structure 4321. In some implementations in which thedevice comprises tabs, the tabs 5724 of the lid 5704 correspond to thetabs of the device (e.g., indicative of continuousness, bias, openings,etc.).

The lid 5704 comprises a plurality of openings 5726 and a centralopening 5728. The openings 5726, 5728 can allow sterilization of thedevice 4301 (e.g., using ethylene oxide), for example through cavity5706. The openings 5726 may allow a user to view the shape of thehousing 4313, ring structure 4321, and/or other features of the device4301. The lid 5704 may be partially or totally opaque. The opening 5728may allow a user to view the refractive surface of the device 4301. Forexample, each of the base 5702 and the lid 5704 may be open to therefractive surface (e.g., the base 5702 via the cavity 5706 and the lid5704 via the opening 5728).

FIG. 57B illustrates example dimensions of the kit 5700. The base 5702may have a length 5730 between about 20 mm and about 100 mm (e.g., about20 mm, about 40 mm, about 50 mm, about 60 mm, about 66 mm, about 70 mm,about 75 mm, about 100 mm, ranges between such values, etc.). The base5702 may have a width 5732 between about 20 mm and about 30 mm (e.g.,about 20 mm, about 22 mm, about 24 mm, about 25 mm, about 25.4 mm, about26 mm, about 27 mm, about 30 mm, ranges between such values, etc.). Alength 5734 from a minor edge of the base 5702 to a position in themiddle of the gap 5712 may be between about 10 mm and about 20 mm (e.g.,about 10 mm, about 12 mm, about 14 mm, about 15 mm, about 15.2 mm, about16 mm, about 20 mm, ranges between such values, etc.). The minor edgesof the base 5702 may have a first radius of curvature 5736 and a secondradius of curvature 5738. The first radius of curvature 5736 may bebetween about 2 mm and about 10 mm (e.g., about 2.5 mm, about 3 mm,about 4 mm, about 5 mm, about 5.1 mm, about 6 mm, about 7.5 mm, about 10mm, ranges between such values, etc.). The first radius of curvature5736 may be between about 20 mm and about 30 mm (e.g., about 20 mm,about 22 mm, about 24 mm, about 25 mm, about 25.4 mm, about 26 mm, about27 mm, about 30 mm, ranges between such values, etc.).

FIG. 57C illustrates further example dimensions of the kit 5700. Adistance or thickness 5740 between an upper surface of the base 5702 anda top surface of the lid 5704 may be between about 5 mm and about 20 mm(e.g., about 5 mm, about 7.5 mm, about 10 mm, about 11 mm, about 11.6mm, about 12 mm, about 15 mm, about 20 mm, ranges between such values,etc.). A thickness of the base 5702 from a lower end to the uppersurface may be between about 2 mm and about 8 mm (e.g., about 2 mm,about 3 mm, about 4 mm, about 4.8 mm, about 5 mm, about 6 mm, about 7mm, about 8 mm, ranges between such values, etc.).

FIG. 58A illustrates an anterior side perspective view of an example ofa prosthetic capsular device 5800. The device 5800 comprises an anteriorside 5802, a posterior side 5804, and sidewalls 5806 extending betweenthe anterior side 5802 and the posterior side 5804. The anterior side5802 comprises an opening 5808. The posterior side 5804 optionallycomprises a refractive surface 5810. The refractive surface 5810 mayhave a diameter between about 4 mm and about 9 mm (e.g., about 4 mm,about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm, rangesbetween such values, etc.).

In some implementations, the prosthetic device 5800 comprises a ringstructure 5820 (e.g., comprising ring structure portions 5820A, 5820B,5820C, 5820D) coupled to a housing structure 5812 comprising theanterior side 5802, posterior side 5804, and sidewalls 5806. In someimplementations, the ring structure 5820 comprises a material that issufficiently strong to maintain the circumference of a natural capsularbag. In some implementations, the ring structure 5820 is configured tobe sufficiently flexible to adjust and conform to the natural shape of anatural capsular bag, which can be asymmetrical. In someimplementations, the ring structure 5820 is configured to secure theprosthetic device 5800 within the natural capsular bag or other eyeregion through a friction fit. For example, the ring structure 5820 cancomprise polyimide, materials known in intraocular lens manufacturingsuch as silicone, collamer, PMMA, acrylic, and acrylates, materials usedin permanent suture applications such as polypropylene, nylon,polytetrafluoroethylene (PTFE), and polyester, shape memory or thermalmemory materials such as nitinol, chromium cobalt, and shape memorypolymers, combinations thereof, and the like. In some implementations,the ring structure 5820 comprises hydrophilic and/or hydrophobicmaterials. The ring structure 5820 may comprise the same or similarproperties or at least one property that is different (e.g., material,composition, dimension, cross-sectional shape, combinations thereof,presence of an aperture, aperture properties, etc.).

In some implementations, the ring structure 5820 comprises four ringportions or haptics 5820A, 5820B, 5820C, 5820D. Other numbers of ringportions are also possible, (e.g., one, two, three, etc.). The ringportions 5820A, 5820B, 5820C, 5820D comprise a radially-outwardlyextending arm 5821 and an aperture section 5827. The arm 5821 may have asingle radius of curvature, a plurality of radii of curvature, bestraight, change direction, have an undulating or sinusoidal shape(e.g., including alternating radially inward troughs and radiallyoutward peaks or apices such as in the devices 4300, 4301), and/or thelike. The ring structure 5820, which is not continuous between points onthe housing structure 5812, may use less material and impart less volumeand/or mass to the device 5800, allowing the device 5800 to be easier toinsert into small incisions. Use of less material may reduce costs dueto use of less material. The arms 5821 can independently move, which canprovide more flexibility than a ring structure that is continuousbetween points on a housing structure.

In implementations in which a device comprises a stretchable housingstructure (e.g., comprising MED-6820 silicone, which is stretchable upto about 200% without damage) and a non-stretchable ring structure(e.g., comprising polyimide) having a ring shape coupled to the housingstructure at two ends (e.g., as in the device 4300), stretching forcesdue to loading or advancing of the device, for example through adelivery syringe or injector cartridge, may break or tear thenon-stretchable ring structure. The ring structure 5820 of the device5800 can inhibit or prevent tearing of the ring structure 5820 and/orthe housing structure 5812.

The ring portions 5820A, 5820B, 5820C, 5820D are individually anchoredto the housing structure 5812 and are not coupled to the housingstructure 5812 at two ends such that stretching forces are independentand generally unidirectional for each ring portion 5820A, 5820B, 5820C,5820D. Individual anchoring or not being connected to each other canalso inhibit or prevent the possibility of crimping the ring structurematerial as the device is folded and advanced through an injector.

The amount of stretch can increase exponentially from the end portionstowards the center of the device 5800. Each of the ring portions 5820A,5820B, 5820C, 5820D is anchored on a side portion of the device 5800between the end portions and proximate to the end portions. Anchoringthe ring portions 5820A, 5820B, 5820C, 5820D proximate to the endportions reduces the amount of stretch experienced by the ring portions5820A, 5820B, 5820C, 5820D at their anchor points.

The curvature of the arms 5821 of the ring portions 5820A, 5820B, 5820C,5820D may be configured to maintain a natural capsular bag in an openposition in the area outside the walls of the device 5800. The curvatureof the arms 5821 can maintain an effective diameter 5842 that is similarto or the same as other devices described herein having a circularhousing structure, having a circular ring structure, etc. The design ofthe device 5800 reduces the volume of material at the center, forexample compared to other devices including housing structure materialand/or ring structure material at the center, where the relatively thickor bulky refractive portion 5810 already resides and where stretchingforces are the highest. Reducing the volume of structural materials ofthe device 5800 near the center of the major axis can allow the device5800 to fit through a small incision size.

The ring portions 5820A, 5820B, 5820C, 5820D comprise aperture sections5827 comprising holes or apertures or openings or eyelets 5828. Theopenings 5828 may be used, for example, to suture the device 5800 to aneye. The openings 5828 illustrated in FIGS. 58A, 58B, and 58E extend allof the way through the aperture sections 5827, but could extend onlypartially through the aperture sections 5827. The openings 5828 mayassist in suturing the device 5800, allow fibrosis therethrough, etc.The ring structure 5820 may comprise more or fewer openings 5828,openings 5828 at different locations (e.g., along an arm 5821 betweenthe housing structure 5812 and the aperture section 5827), etc. Theopenings 5828 may be formed, for example, by photo-etching and/or lasermilling polyimide.

Like the device 4300 in which the ring structure 4320 is embedded in atleast a portion of the housing structure 4312 by anchors 4320C, 4320D,the ring structure 5820 is embedded in at least a portion of the housingstructure 5812 by anchors 5822. In the device 5800, each of the ringportions 5820A, 5820B, 5820C, 5820D comprises an anchor 5822 comprisinga first anchor portion 5822A that extends in a first direction (e.g.,from the ring portion 5820B towards the ring portion 5820D) and a secondportion 5822B that extends in a second direction different than thefirst direction (e.g., along side portions of the housing structure5812; from the ring portion 5820B towards the ring portion 5820A). Thefirst anchor portion 5822A and the second anchor portion 5822B maycomprise the same or similar properties or at least one property that isdifferent (e.g., material, composition, dimension, cross-sectionalshape, combinations thereof, etc.). The anchor portions 5822 maycomprise the same or similar properties or at least one property that isdifferent (e.g., material, composition, dimension, cross-sectionalshape, combinations thereof, etc.). The anchors 5822 and the radiallyoutward projections or haptics of the ring structure 5820 may comprisethe same or similar properties or at least one property that isdifferent (e.g., material, composition, dimension, cross-sectionalshape, combinations thereof, etc.). As discussed with respect to the endanchors 2260 of FIG. 22B, the longitudinal anchors 5822A extendpartially along a length of the end portions of the housing structure5812. The longitudinal anchors 5822A could extend along the entirelength of the end portions of the housing structure 5812, along the endportions by different amounts, change direction, etc. As discussed as anoptional variant of FIG. 22B, the longitudinal anchors 5822B extendpartially along a length of the side portions of the housing structure5812. The longitudinal anchors 5822B could extend along the entirelength of the side portions of the housing structure 5812, along theside portions by different amounts, change direction, etc. In someimplementations, at least one of the ring portions 5820A, 5820B, 5820C,5820D may comprise an anchor portion 5822 that is different than atleast one other anchor portion 5822.

The device 5800 optionally comprises a bulge 5816 extending radiallyoutward of the sidewalls 5806. The device 5800 shown in FIGS. 58A-58Eincludes a bulge 5816 on each end portion. The housing structure 5812may comprise the bulge 5816 (e.g., the bulge 5816 being integral withthe housing structure 5812). In some implementations, the ring structure5820 is placed in a mold and the housing structure 5812 is overmoldedaround the ring structure 5820. The bulge 5816 may be coupled to thehousing structure 5812. The bulge 5816 may comprise the same material asthe housing structure 5812 or a different material than the housingstructure 5812. The bulge 5816 may allow the anchors 5822 to besubstantially radially aligned with the sidewalls 5806. The bulge 5816may provide extra material in which the ring structure 5820 may anchor,for example maintaining a wall thickness (e.g., about 0.2 mm) on one orboth sides of the ring structure 5820 with or without the use of aprimer. The bulge 5816 may allow the material of the housing structure5812 to surround (e.g., completely surround) the anchoring portions 5822of the ring portion 5820, which can avoid an area of weakness and/ordiscontinuity of the housing structure 5812. The device 5800 includesbulges 5816 that extend along the entire edge portions of the housingstructure 5812, even beyond the termination of the anchor portions5822A. In some implementations, the device includes bulges 5816 thatextend slightly beyond the termination of the anchor portions 5822A.

The device 5800 optionally comprises a posterior fin 5824. The device5800 shown in FIGS. 58A-58E includes two posterior fins 5824. Theposterior fins 5824 are aligned along a diameter of the refractivesurface 5810 and in line with the major axis of the prosthetic device5800. In some implementations, a plurality of posterior fins 5824 (e.g.,2, 3, 4, 5, 6, or more fins 5824) may be circumferentially offset (e.g.,by about 180°, by about 120°, by about 90°, by about 72°, by about 60°,and the like). In some implementations, at least some or all of aplurality of posterior fins 5824 (e.g., 2, 3, 4, 5, 6, or more fins5824) may be unaligned. The posterior fins 5824 are aligned along amajor axis of the device 5800. In some implementations, the posteriorfins 5824 may be aligned along a minor axis of the device 5800. In someimplementations, the posterior fins 5824 may be unaligned along an axisof the device 5800 (e.g., at an angle with respect to the major axisand/or the minor axis). The housing structure 5812 may comprise theposterior fin 5824 (e.g., the posterior fin 5824 being integral with thehousing structure 5812). The posterior fin 5824 may be coupled to thehousing structure 5812. The posterior fin 5824 may comprise the samematerial as the housing structure 5812 or a different material than thehousing structure 5812. The posterior fin 5824 may help to space aposterior surface of a natural capsular bag from the posterior end 5804of the housing structure 5812 radially outward of the refractive surface5810. Spacing the posterior surface of the natural capsular bag from theposterior end 5804 of the housing structure 5812 radially outward of therefractive surface 5810 may allow fluid flow radially outward of therefractive surface 5810, which may help to reduce opacification. Spacingthe posterior surface of the natural capsular bag from the posterior end5804 of the housing structure 5812 radially outward of the refractivesurface 5810 may reduce the chance of retaining viscoelastic that hassome residual trapped fibrin or inflammatory precipitate containedwithin it.

In embodiments in which the fins 5824 are aligned with the major axis ofthe device 5800, the device 5800 can be strategically aligned in an eye.For example, if an eye has astigmatism, a device 5800 in which therefractive surface 5810 comprises a toric lens can be used to at leastpartially correct the astigmatism if the device 5800 is properlyoriented (e.g., with the steep axis of a cornea). In someimplementations, at least one of the fins 5824 can be different (e.g.,different shape, dimensions, etc.) to indicate a top or bottom of thedevice 5800. In devices allowing any rotational orientation of an IOLinserted therein, a toric IOL can be rotated. The device 5800 includestruncated sides, reducing volume and in some cases advantageouslylimiting rotation of an IOL inserted therein. Aligning the device 5800for alignment of a toric refractive surface 5810 and/or a toric IOLcontained in the device 5800 can advantageously provide the advantagesof limited IOL rotation, reduced volume, and astigmatism correction.

FIG. 58B illustrates an anterior plan view of the example prostheticcapsular device 5800 of FIG. 58A. The prosthetic capsular device 5800has a major axis along the line 58C-58C and a minor axis along the line58D-58D. FIG. 58C illustrates a cross-sectional view of the exampleprosthetic capsular device 5800 of FIG. 58A along the line 58C-58C ofFIG. 58B. FIG. 58D illustrates a cross-sectional view of the exampleprosthetic capsular device 5800 of FIG. 58A along the line 58D-58D ofFIG. 58B. FIGS. 58B-58D illustrate example dimensions of the device5800.

As seen in FIG. 58A, but perhaps best seen in FIGS. 58C and 58D, thering structure 5820 extends from the housing structure 5812 at aposition anterior to a longitudinal midline of the device 5800, whichmay inhibit or prevent the anterior capsule and the posterior capsulefrom fusing. The fins 5824 may also help to spatially separate theanterior capsule and the posterior capsule to inhibit or prevent theanterior capsule and the posterior capsule from fusing.

The outer diameter 5840 of the housing structure 5812, including thebulge 5816, may be between about 9 mm and about 11 mm (e.g., about 9 mm,about 9.5 mm, about 10 mm, about 10.5 mm, about 11 mm, ranges betweensuch values, etc.). The thickness 5854 of the housing structure 5812,including the bulge 5816, along the minor axis may be between about 6 mmand about 8 mm (e.g., about 6 mm, about 6.25 mm, about 6.5 mm, about6.75 mm, about 7 mm, about 7.25 mm, about 7.5 mm, about 7.75 mm, about 8mm, ranges between such values, etc.). The outer or under certaincircumstances maximum diameter 5842 of the device 5800, for exampleaccounting for extension of the ring structure 5820, may be betweenabout 9 mm and about 12 mm (e.g., about 9 mm, about 9.5 mm, about 10 mm,about 10.3 mm, about 10.5 mm, about 11 mm, about 12 mm, ranges betweensuch values, etc.). In some implementations, a diameter greater than 10mm may impart outward forces on a natural capsular bag that may tear thebag such that a diameter of about 10 mm or less may be preferred.

The length 5870 of the opening 5808 in the anterior side 5802 along themajor axis may be between about 6 mm and about 8 mm (e.g., about 6 mm,about 6.5 mm, about 7 mm, about 7.5 mm, about 8 mm, ranges between suchvalues, etc.). The length 5858 of the opening 5808 in the anterior side5802 along the minor axis may be between about 5 mm and about 7 mm(e.g., about 5 mm, about 5.5 mm, about 6 mm, about 6.5 mm, about 7 mm,ranges between such values, etc.). The opening 5808 illustrated in FIGS.58A-58D is oblong, with the length 5870 being greater than the length5858, but is not as oblong as the housing structure 5812. In someimplementations, a ratio of a major axis opening length to a minor axisopening length is between about 1:2 and 2:1 (e.g., 1:2, 2:3, 3:4, 4:5,5:6, 6:7, 7:8, 8:9, 9:10, 10:9, 9:8, 8:7, 7:6, 6:5, 5:4, 4:3, 3:2, 2:1,ranges between such values, etc.). For example, major axis openinglength may be shorter than the minor axis opening length. In someimplementations, the opening 5808 may be circular, more oblong, lessoblong, and/or include straight portions. A larger opening 5808 mayallow more light to pass to the refractive surface 5810 and/or an IOL inthe device 5800 such that light is less likely to refract off anteriorsurfaces and create dysphotopsias.

The distance 5856 between the centers of the openings 5828 of the ringportions 5820 on opposite sides of the major axis may be between about 8mm and about 10 mm (e.g., about 8 mm, about 8.25 mm, about 8.5 mm, about8.75 mm, about 9 mm, about 9.25 mm, about 9.5 mm, about 9.75 mm, about10 mm, ranges between such values, etc.). The distance 5846 between theopenings 5828 of the ring portions 5820 on opposite sides of the minoraxis may be between about 2 mm and about 4 mm (e.g., about 2 mm, about2.25 mm, about 2.5 mm, about 2.75 mm, about 3 mm, about 3.25 mm, about3.5 mm, about 3.75 mm, about 4 mm, ranges between such values, etc.).The diameter 5844 of the openings 5828 may be between about 0.2 mm andabout 0.3 mm (e.g., about 0.2 mm, about 0.25 mm, about 0.3 mm, rangesbetween such values, etc.). The diameters 5844 of the openings 5828 maybe the same or different. The dimensions described herein can affectposition of the device 5800 with respect to the circumference of thescleral wall. For example, if the holes 5828 are used to suture thedevice 5800 to the scleral wall, the holes 5828 are preferably spaced orfar enough away from each other to provide stable anchor points that arepreferably symmetrical.

As the device 5800 is folded along the major axis for insertion in aneye, the refractive surface 5810 can stretch along the minor axis. Insome implementations, the refractive surface 5810 can stretch at leastabout 110%, about 120%, about 130%, about 140%, about 150%, about 160%,about 170%, about 180%, about 190%, about 200%, or more. In someimplementations, the refractive surface 5810 can stretch between about110% and about 600% (e.g., about 110%, about 120%, about 130%, about140%, about 150%, about 160%, about 170%, about 180%, about 190%, about200%, about 250%, about 300%, about 350%, about 400%, about 450%, about500%, about 550%, about 600%, ranges between such values, less thanabout 110% (e.g., between about 0% and about 110%), greater than about200%, greater than about 300%, greater than about 400%, greater thanabout 500%, greater than about 600%, etc.).

The ring structure 5820 may have a thickness 5860 between about 0.1 mmand about 0.15 mm (e.g., about 0.1 mm, about 0.11 mm, about 0.12 mm,about 0.125 mm, about 0.13 mm, about 0.14 mm, about 0.15 mm, rangesbetween such values, etc.). A distance 5862 between the ring structure5820, for example measured at an approximate midpoint, and the posteriorside 5804 may be between about 0.25 mm and about 2.5 mm (e.g., about0.25 mm, about 0.5 mm, about 0.75 mm, about 1 mm, about 1.25 mm, about1.5 mm, about 1.75 mm, about 2 mm, about 2.5 mm, ranges between suchvalues, etc.). The longitudinal position of the ring structure 5820 maybe more proximate to the anterior side 5802 or the posterior side 5804,for example based on expected interaction with a natural capsular bag.At least one of the ring portions 5820A, 5820B, 5820C, 5820D may have adifferent longitudinal position than at least one other of the ringportions 5820A, 5820B, 5820C, 5820D.

The thickness 5864 of a wall of the posterior side 5804 radially outwardof the refractive surface 5810 may be between about 0.1 mm and about 0.4mm (e.g., about 0.1 mm, about 0.15 mm, about 0.2 mm, about 0.25 mm,about 0.3 mm, about 0.35 mm, about 0.4 mm, ranges between such values,etc.). In some implementations, the sidewalls 5806 may be thicker orthinner than the posterior wall. The posterior fin 5824 may protrudefrom the posterior wall by a distance 5872 between about 0.05 mm andabout 0.2 mm (e.g., about 0.05 mm, 0.1 mm, about 0.15 mm, about 0.2 mm,about 0.25 mm, about 0.3 mm, about 0.35 mm, about 0.4 mm, ranges betweensuch values, etc.). The thickness 5866 of the device 5800 between theanterior side 5802 and the posterior side 5804 may be between about 2 mmand about 3 mm (e.g., about 2 mm, about 2.25 mm, about 2.5 mm, about2.75 mm, about 3 mm, ranges between such values, etc.). The thickness5868 of the device 5800 between the anterior side 5802 under the lip5814 and the inside of the posterior wall may be between about 2 mm andabout 3 mm (e.g., about 2 mm, about 2.25 mm, about 2.5 mm, about 2.75mm, about 3 mm, ranges between such values, etc.).

The posterior fin 5824 may be spaced from the refractive surface 5810 bya spacing or distance 5848 between about 0.05 mm and about 0.2 mm (e.g.,about 0.05 mm, 0.1 mm, about 0.15 mm, about 0.2 mm, about 0.25 mm, about0.3 mm, about 0.35 mm, about 0.4 mm, ranges between such values, etc.).The posterior fin 5824 may have a thickness 5850 between about 0.5 mmand about 2 mm (e.g., about 0.5 mm, about 0.6 mm, about 0.7 mm, about0.8 mm, about 0.9 mm, about 1 mm, about 1.25 mm, about 1.5 mm, about1.75 mm, about 2 mm, ranges between such values, etc.). The posteriorfin 5824 may have a thickness 5852 between about 0.05 mm and about 0.2mm (e.g., about 0.05 mm, 0.1 mm, about 0.15 mm, about 0.2 mm, about 0.25mm, about 0.3 mm, about 0.35 mm, about 0.4 mm, ranges between suchvalues, etc.). The spacing 5848, length 5850, thickness 5852, and/ordistance 5872 may vary, for example based on the properties of therefractive surface 5810 (e.g., a larger distance 5872 for a largerdiopter value).

FIG. 58E illustrates an anterior plan view of an example prostheticcapsular device 5880. The device 5880 is similar to the device 5800except for the ring structure 5820. The arms 5881 may be different thanthe arms 5821, the aperture sections 5882 may be different than theaperture sections 5827, and/or the holes 5883 may be different than theholes 5828. A ring portion 5820C of the device 5800 is shown in phantomfor comparison to the ring portions of the device 5880.

The diameter 5845 of the openings 5883 may be between about 0.3 mm andabout 0.4 mm (e.g., about 0.3 mm, about 0.35 mm, about 0.4 mm, rangesbetween such values, etc.). The diameters 5845 of the openings 5883 maybe the same or different. The diameter 5845 may be less than thediameter 5844. The diameter difference may be between about 0.05 mm andabout 0.2 mm (e.g., about 0.05 mm, 0.1 mm, about 0.15 mm, about 0.2 mm,about 0.25 mm, about 0.3 mm, about 0.35 mm, about 0.4 mm, ranges betweensuch values, etc.). Larger openings 5883 may provide more surface areafor fibrosis therethrough. The diameter 5874 of the aperture sections5882 may be between about 0.4 mm and about 0.8 mm (e.g., about 0.4 mm,0.5 mm, about 0.6 mm, about 0.7 mm, about 0.8 mm, ranges between suchvalues, etc.). The diameter 5874 may be larger than the diameter of theaperture sections 5827 of the device 5800, for example to accommodatelarger openings 5883.

Larger openings 5883 may provide easier suturing and/or be better ableto securely hold a suture (e.g., comprising PTFE) for the potentialscleral fixation of the device 5800 to the sclera. For example, one passof a suture may go under the device 5800 and through a first opening5833 and another pass of the suture may go over top the device 5800,through a second opening 5833 (e.g., the opening on the same side of themajor axis), under the device 5800 and through a third opening 5833(e.g., the opening on the same side of the minor axis as the secondopening), and over the top of the device 5800 and through a fourthopening 5833 (e.g., the opening on the same side of the major axis asthe third opening), passing through the midvitreous cavity after avitrectomy. Once the suture(s) has/have been passed, suture slack can bereduced and a 3-1-1 suture placement tie can be performed using astraight tie, a kelman tie, etc. may be used to secure the suture to thesclera. Knots may be tucked into the sclerotomy. The ability to affixthe device 5800 to the sclera may be particularly advantageous, forexample, for subjects who have had a total loss of capsular support dueto surgical trauma, unintended eye trauma, congenital weakness of thezonules, etc.

In embodiments in which the openings 5883 have a diameter of at leastabout 0.35 mm, the openings 5883 are large enough to allow a surgeon toengage the openings 5883 with a standard IOL positioning tool such as aLester IOL manipulator, which may include a tip that is angled up to 90°and have a diameter between 0.2 mm and 0.25 mm.

The distance 5857 between the centers of the openings 5883 of the ringportions on opposite sides of the major axis may be between about 8 mmand about 10 mm (e.g., about 8 mm, about 8.25 mm, about 8.5 mm, about8.75 mm, about 9 mm, about 9.25 mm, about 9.5 mm, about 9.75 mm, about10 mm, ranges between such values, etc.).

The distance 5857 may be less than the distance 5856, indicative thatthe centers of the openings 5883 are closer to the housing structure inthe device 5880 than the centers of the openings 5828 are to the housingstructure 5812 in the device 5800. The aperture sections 5882 may havethe same radial extension as the device 5800, but the larger size of theaperture sections 5882 and the openings 5883 may extend radially inwardsuch that the centers of the openings are also radially inward. Thedistance difference may be between about 0.05 mm and about 0.2 mm (e.g.,about 0.05 mm, 0.1 mm, about 0.15 mm, about 0.2 mm, about 0.25 mm, about0.3 mm, about 0.35 mm, about 0.4 mm, ranges between such values, etc.).The distance between the openings 5883 of the ring portions on oppositesides of the minor axis may be the same as or different than the device5800.

The dimensions described herein can affect position of the device 5880with respect to the circumference of the scleral wall. For example, ifthe holes 5883 are used to suture the device 5880 to the scleral wall,the holes 5883 are preferably spaced or far enough away from each otherto provide stable anchor points that are preferably symmetrical.

FIG. 58F illustrates an anterior plan view of the example prostheticcapsular device 5885. The device 5885 is similar to the devices 5880,5880 except for the ring structure. The arms 5886 may be different thanthe arms 5821 and/or the arms 5881, the aperture sections 5887 may bedifferent than the aperture sections 5827 and/or the aperture sections5882, and/or the holes 5888 may be different than the holes 5828 and/orthe holes 5883. A ring portion 5820C of the device 5800 is shown inphantom for comparison to the ring portions of the device 5885.

The outer or under certain circumstances maximum diameter 5843 of thedevice 5885, for example accounting for extension of the ring structure,may be between about 10 mm and about 13 mm (e.g., about 10 mm, about10.5 mm, about 11 mm, about 11.5 mm, about 12 mm, about 12.5 mm, about13 mm, ranges between such values, etc.). The housing structure may havethe same dimensions as the housing structure 5812 of the device 5800,indicative that the change in maximum diameter due to extension of thering structure. The device 5885 can provide a larger maximum diameter,which may better conform to a natural capsular bag (e.g., providingtension on and/or increasing stability in a natural capsular bag havinga larger than average diameter), while also maintaining advantages dueto the use of less material for the housing structure (e.g., insertionthrough a smaller incision size).

The diameter 5845 of the openings 5888 may the same as the diameter 5845of the openings 5883 and/or the diameter 5874 of the aperture sections5887 may be the same as the diameter 5874 of the aperture sections 5882.

The distance 5847 between the centers of the openings 5888 of the ringportions on opposite sides of the minor axis may be between about 3 mmand about 5 mm (e.g., about 3 mm, about 3.25 mm, about 3.5 mm, about3.75 mm, about 4 mm, about 4.25 mm, about 4.5 mm, about 4.75 mm, about 5mm, ranges between such values, etc.). The distance 5859 between thecenters of the openings 5888 of the ring portions on opposite sides ofthe major axis may be between about 9 mm and about 11 mm (e.g., about 9mm, about 9.25 mm, about 9.5 mm, about 9.75 mm, about 10 mm, about 10.25mm, about 10.5 mm, about 10.75 mm, about 11 mm, ranges between suchvalues, etc.).

The distance 5847 may be greater than the distance 5846, indicative thatthe centers of the openings 5888 are farther from each other than thecenters of the openings 5828 are from each other. The aperture sections5887 have further radial extension than in the device 5800, for exampledue to a different angle and/or curvature of the arms 5886. The distancedifference may be between about 0.05 mm and about 0.2 mm (e.g., about0.05 mm, 0.1 mm, about 0.15 mm, about 0.2 mm, about 0.25 mm, about 0.3mm, about 0.35 mm, about 0.4 mm, ranges between such values, etc.).

The distance 5859 may be greater than the distance 5856 and/or thedistance 5857, indicative that the centers of the openings 5888 arefarther from the housing structure in the device 5885 than the centersof the openings 5828 are to the housing structure 5812 in the device5800 and the centers of the openings 5883 are to the housing structurein the device 5880. The aperture sections 5887 have further radialextension than in the device 5800, for example due to a different angleand/or curvature of the arms 5886. The distance difference may bebetween about 0.05 mm and about 0.2 mm (e.g., about 0.05 mm, 0.1 mm,about 0.15 mm, about 0.2 mm, about 0.25 mm, about 0.3 mm, about 0.35 mm,about 0.4 mm, ranges between such values, etc.).

The dimensions described herein can affect position of the device 5885with respect to the circumference of the scleral wall. For example, ifthe holes 5888 are used to suture the device 5885 to the scleral wall,the holes 5888 are preferably spaced or far enough away from each otherto provide stable anchor points that are preferably symmetrical.

FIG. 58G illustrates an anterior plan view of an example prostheticcapsular device system 5890. The prosthetic capsular device system 5890comprises the prosthetic capsular device 5880 and an intraocular lens5892. The intraocular lens 5892 comprises haptics 5894 extendingradially outward from a refractive portion 5896. The haptics 5894 thenturn generally coaxial with the refractive portion 5896 to be radiallyoutward of and spaced from the refractive portion 5896. The system 5890may comprise other types of intraocular lenses 5892 including, but notlimited to: spherical, aspheric, wavefront, convex, concave, multifocal(diffractive, refractive, zonal), toric, accommodative, ultraviolet (UV)filtering, and diffractive chromatic aberration reducing lenses, andlight adjustable lenses (ultraviolet light adjustable, femtosecond phasewrapping) and optical powers ranging from any positive diopter value(e.g., including +35 D and above) to any negative diopter value (e.g.,including −35 D and below), and including any prism power (including 60Prism Diopters and above). The system 5890 may include a component of anoptical system designed to work in conjunction with the refractive lensof the prosthetic capsular device, which can create a polypseudophakicoptical system such as a telescope, or provide modification of multiplerefractive qualities (e.g. astigmatism, spherical aberration, extendeddepth of focus, and/or multifocality).

All of the prosthetic capsular devices described herein can provide forthe creation of a complex refractive system comprising one or aplurality of components. For example, a refractive surface comprising atoric lens may be able to correct sphere or sphere and astigmatismand/or create multifocal vision. The prosthetic capsular device caninclude other optical components instead of or in addition to aspherical and/or toric lens. A plurality of components can fine tune thevision to levels previously impossible. For example, the refractivesurface of the prosthetic capsular device can correct sphere; then,astigmatism, spherical aberration, multifocality, and/or chromaticaberrations could be further corrected with the addition of lensesstacked on top of the refractive surface. If the optic contains a lightadjustable material, the optical power can be changed through theexternal light application. A plurality of other lenses inside theprosthetic capsular device can create complex optical systems. Foranother example, a telescope can be created to allow magnification ofimages in subjects with severe retinal pathologies such as maculardegeneration. In some implementations, a telescope implant, such asavailable from VisionCare Ophthalmic Technologies of Saratoga, Calif., adual-lens system that creates magnification through telescopicprinciples, etc., can be contained in the prosthetic capsular device.For example, the prosthetic capsular device could comprise a stronglynegative lens and a strongly positive lens could be placed in theciliary sulcus or in the prosthetic capsular device. If the subjectcannot adapt to or tolerate the change, the assembly is totallyreversible. The device allows removal of components such as IOLs,additional components, telescope implants, etc. and provides a barrierto vitreous, even after a Nd:YAG laser posterior capsulotomy. The“plug-and-play” abilities provided by the prosthetic capsular device canallow the creation of different vision tuning at different times, forexample based on physiological changes and technological updates. Theprosthetic capsular device can comprise a prism (e.g., the refractivesurface can comprise a prism), which may shift images away from adamaged retina (e.g., in ARMD or other maculopathy patients). Insubjects having eyes that are misaligned, a prism could help resolvedouble vision.

Like the sidewalls of the devices 400, 1000, 1100, 1150, 1250, 2250,2300, 2900, 3100, 4300, 4301, for example, the sidewalls 5806 of thedevices 5800, 5880, 5885 include a first straight-walled portionextending anteriorly from the posterior surface 5804 and a second partthat tapers radially-inwardly toward the opening 5808 of the anteriorsurface 5802. The first and second parts may be identified by atransition point, or may be identified based on the properties (e.g.,shape, function, etc.) of the parts. The straight-walled portion of thesidewalls 5806 may be parallel or substantially parallel with alongitudinal axis of the device 5800. The straight-walled portion of thesidewalls 5806 may be orthogonal or substantially orthogonal to a flatportion of the posterior surface (e.g., radially outward of therefractive portion 5810). The straight-walled portion of the sidewalls5806 may be orthogonal or substantially orthogonal to the opening 5808.The straight-walled portion of the sidewalls 5806 can increase space inthe cavity of the device 5800. The space can be used for intraocularlenses, other optical devices, drug eluting devices, electronic devices,and the like. The device 5800, like other devices described herein,provides a platform for insertion, and even removal, of various articlesinto an eye, and increased cavity space opens that platform to morearticles.

FIGS. 58H-58L illustrate anterior plan views of example prostheticcapsular devices comprising different numbers of ring portions. In FIG.58H, the device 58801 comprises two ring portions 58201A, 58201B thatare on opposite sides of the major axis and on opposite sides of theminor axis. In FIG. 58I, the device 58802 comprises two ring portions58202A, 58202B that are on opposite sides of the major axis and on thesame side of the minor axis. In FIG. 58J, the device 58803 comprises tworing portions 58203A, 58203B that are on the same side of the major axisand on opposite sides of the minor axis. In FIG. 58K, the device 58804comprises one ring portion 58204. In FIG. 58L, the device 58805comprises three ring portions 58205A, 58205B, 58205C in which the ringportions 58205A, 58205B are on the same side of the major axis and onopposite sides of the minor axis, the ring portions 58205A, 58205C areon opposite sides of the major axis and on opposite sides of the minoraxis, and the ring portions 58205B, 58205C are on opposite sides of themajor axis and the same side of the minor axis. Other numbers andconfigurations of ring portions are also possible. In someimplementations comprising one ring structure on a side of the majoraxis, the arm of the ring structure may be longer, including extendingup to or even abutting but not anchored in the housing structure on theother side of the minor axis.

FIG. 61A illustrates an anterior side perspective view of an exampleprosthetic capsular device 6100. FIG. 61B illustrates an anterior planview of the example prosthetic capsular device 6100 of FIG. 61A. FIG.61C illustrates a side view of the example prosthetic capsular device6100 of FIG. 61A. The device 6100 comprises openings 6126A, 6126B in thehousing structure 6112. The opening 6126A may be the same or differentthan the opening 6126B. An inserted device (e.g., an intraocular lens orother device) may be inside the housing structure 6112 of the device6100 and/or project through one or both of the openings 6126A, 6126B tothe unoccupied capsular recess. The openings 6126A, 6126B may allowrotation of the inserted device, for example comprising a lens thatneeds to be rotated (e.g., for astigmatism correction). The openings6126A, 6126B may allow delivery of a medicament (including but notlimited to therapeutic agents in the form of pharmaceuticals, biologicagents, monoclonal antibodies, gene therapy and gene vectors, radiationtherapy, chemotherapeutic agents, engineered cell culture products) froman inserted drug delivery platform (including but not limited totraditional platforms and non-traditional platforms engineered cellculture biologic agent monoclonal antibody and/or protein producingimplants) through one or both of the openings 6126A, 6126B into thenatural capsular bag and into the vitreous or posterior segment. Theopenings 6126A, 6126B may provide access the unoccupied space of thehousing structure 6112, for example to store a battery, microchip, orother opaque piece of technology that is desirably held outside of thevisual axis or pupillary aperture.

The openings 6126A, 6126B illustrated in FIGS. 61A-61C are between thering structure portions 6120A, 6120B and between the ring structureportions 6120C, 6120D, respectively. Other positions, quantities, andshapes of the openings are also possible. For example, the device 6100may also or alternatively comprise openings between the ring structureportions 6120A, 6120C and/or between the ring structure portions 6120B,6120D. The device 6100 may comprise only one opening, only two openings,or more than two openings. The device 6100 may comprise a firstplurality of openings between the ring structure portions 6120A, 6120Band/or a second plurality of openings between the ring structureportions 6120C, 6120D. A plurality of openings smaller than the openings6126A, 6126B may increase the structural integrity of the device 6100and/or inhibit lens epithelial cell growth into the cavity of thehousing structure 6112 while still providing at least one of thepotential advantages described herein.

The openings 6126A, 6126B are illustrated as being mirror-image ovalopenings, but other shapes are also possible (e.g., polygonal (e.g.,rectangular), arcuate (e.g., circular, ellipsoid, oval), slits,combinations thereof, and the like). For example, the openings 6126A,6126B may comprise oval openings with a series of struts 6152 alignedwith the longitudinal axis (e.g., as shown with respect to the opening6176B of the device 6150 of FIG. 61D) and/or a series of triangularstruts.

The openings 6126A, 6126B may be formed during formation of the housingstructure 6112 (e.g., as part of a molding process) and/or formed afterformation of the housing structure 6112 (e.g., by a laser, chemical, ormechanical removal process). In some implementations, the housingstructure 6112 may comprise a different material around the openings6126A, 6126B (e.g., the housing structure 6212 comprising silicone andthe opening surrounding material comprising polyimide). In someimplementations, the housing structure 6112 may comprise thickermaterial around the openings 6126A, 6126B (e.g., to buttress theopenings 6126A, 6126B, for example if another device is to be anchoredto the opening 6126A, 6126B). In some implementations, the housingstructure 6112 may comprise thinner material around the openings 6126A,6126B (e.g., for easier removal of material and/or opening formation).

FIG. 62A illustrates an anterior side perspective view of an exampleprosthetic capsular device 6200. FIG. 62B illustrates an anterior planview of the example prosthetic capsular device 6200 of FIG. 62A. FIG.62C illustrates a side view of the example prosthetic capsular device6200 of FIG. 62A. The device 6200 comprises openings 6226A, 6226B,6226C, 6226D in the housing structure 6212. Each of the openings 6226A,6226B, 6226C, 6226D may be the same as the others of the openings 6226A,6226B, 6226C, 6226D. At least one of the openings 6226A, 6226B, 6226C,6226D may be different than at least one of the other openings 6226A,6226B, 6226C, 6226D. The openings 6226A, 6226B, 6226C, 6226D, which aresmaller than the openings 6126A, 6126B described above, may increase thestructural integrity of the device 6200 and/or inhibit lens epithelialcell growth into the cavity of the housing structure 6212. The openings6226A, 6226B, 6226C, 6226D may allow delivery of a medicament from aninserted drug delivery platform through one, some, or all of theopenings 6226A, 6226B, 6226C, 6226D into the natural capsular bag andinto the vitreous or posterior segment. The openings 6226A, 6226B,6226C, 6226D may provide access the unoccupied space of the housingstructure 6212, for example to store a battery, microchip, or otheropaque piece of technology that is desirably held outside of the visualaxis or pupillary aperture. The openings 6226A, 6226B, 6226C, 6226Dillustrated in FIGS. 62A-62C are posterior to the ring structureportions 6220A, 6220B, 6220C, 6220D, respectively. Other positions,quantities, and shapes of the openings are also possible. For example,the device 6200 may comprise only one opening, only two openings, onlythree openings, only four openings, or more than four openings. Theopenings 6226A, 6226B, 6226C, 6226D may be at a position other thanposterior to the ring structure portions 6220A, 6220B, 6220C, 6220D. Thedevice 6200 may comprise a plurality of openings posterior to the ringstructure portions 6220A, 6220B, 6220C, 6220D or in another position.The openings 6226A, 6226B, 6226C, 6226D are illustrated as beingmirror-image circular openings, but other shapes are also possible(e.g., polygonal (e.g., rectangular), arcuate (e.g., circular,ellipsoid, oval), slits, combinations thereof, and the like). Theopenings 6226A, 6226B, 6226C, 6226D may provide an anchor point, forexample interacting with a protrusion, for another device to be held inthe capsule of the device 6200 or outside the device 6200. The openings6226A, 6226B, 6226C, 6226D may be formed during formation of the housingstructure 6212 (e.g., as part of a molding process) and/or formed afterformation of the housing structure 6212 (e.g., by a laser, chemical, ormechanical removal process). In some implementations, the housingstructure 6212 may comprise a different material around the openings6226A, 6226B, 6226C, 6226D (e.g., the housing structure 6212 comprisingsilicone and the opening surrounding material comprising polyimide). Insome implementations, the housing structure 6212 may comprise thickermaterial around the openings 6226A, 6226B, 6226C, 6226D (e.g., tobuttress the openings 6226A, 6226B, 6226C, 6226D, for example if anotherdevice is to be anchored to the opening 6226A, 6226B, 6226C, 6226D). Insome implementations, the housing structure 6212 may comprise thinnermaterial around the openings 6226A, 6226B, 6226C, 6226D (e.g., foreasier removal of material and/or opening formation).

FIG. 63A illustrates an anterior side perspective view of an exampleprosthetic capsular device 6300. FIG. 63B illustrates an anterior planview of the example prosthetic capsular device 6300 of FIG. 63A. FIG.63C illustrates a side view of the example prosthetic capsular device6300 of FIG. 63A. The device 6300 comprises openings 6326A1, 6326B1,6326C1, 6326D1, 6326A2, 6326B2, 6326C2, 6326D2 in the housing structure6312. The openings 6326A1, 6326B1, 6326C1, 6326D1 illustrated in FIGS.63A-63C are posterior to the ring structure portions 6320A, 6320B,6320C, 6320D, respectively. The openings 6326A2, 6326B2, 6326C2, 6326D2illustrated in FIGS. 63A-63C are anterior to the ring structure portions6320A, 6320B, 6320C, 6320D, respectively. In some implementations, theopenings 6326A1, 6326B1, 6326C1, 6326D1 may provide better access to thenatural capsular bag (e.g., for transmission of medicaments). In someimplementations, the openings 6326A2, 6326B2, 6326C2, 6326D2 may beeasier to access from an anterior incision. Other positions, quantities,and shapes of the openings are also possible. For example, the device6300 may comprise only one opening, only two openings, only threeopenings, only four openings, only five openings, only six openings,only seven openings, only eight openings, or more than eight openings.The openings 6326A1, 6326B1, 6326C1, 6326D1 may be at a position otherthan posterior to the ring structure portions 6320A, 6320B, 6320C,6320D. The openings 6326A2, 6326B2, 6326C2, 6326D2 may be at a positionother than anterior to the ring structure portions 6320A, 6320B, 6320C,6320D. The device 6300 may comprise a plurality of openings posterior tothe ring structure portions 6320A, 6320B, 6320C, 6320D, a plurality ofopenings anterior to the ring structure portions 6320A, 6320B, 6320C,6320D, or in another position. The openings 6326A1, 6326B1, 6326C1,6326D1 and the openings 6326A2, 6326B2, 6326C2, 6326D1 are eachillustrated as being mirror-image circular openings, but other shapesare also possible (e.g., polygonal (e.g., rectangular), arcuate (e.g.,circular, ellipsoid, oval), slits, combinations thereof, and the like).Each of the openings 6326A1, 6326B1, 6326C1, 6326D1, 6326A2, 6326B2,6326C2, 6326D2 may be the same as the others of the openings 6326A1,6326B1, 6326C1, 6326D1, 6326A2, 6326B2, 6326C2, 6326D2. At least one ofthe openings 6326A1, 6326B1, 6326C1, 6326D1, 6326A2, 6326B2, 6326C2,6326D2 may be different than at least one of the other openings 6326A1,6326B1, 6326C1, 6326D1, 6326A2, 6326B2, 6326C2, 6326D2. The openings6326A1, 6326B1, 6326C1, 6326D1, 6326A2, 6326B2, 6326C2, 6326D2, whichare smaller than the openings 6126A, 6126B described above, may increasethe structural integrity of the device 6300 and/or inhibit lensepithelial cell growth into the cavity of the housing structure 6312.The openings 6326A1, 6326B1, 6326C1, 6326D1, 6326A2, 6326B2, 6326C2,6326D2 may allow delivery of a medicament from an inserted drug deliveryplatform through one, some, or all of the openings 6326A1, 6326B1,6326C1, 6326D1, 6326A2, 6326B2, 6326C2, 6326D2 into the natural capsularbag and into the vitreous or posterior segment. The openings 6326A1,6326B1, 6326C1, 6326D1, 6326A2, 6326B2, 6326C2, 6326D2 may provideaccess the unoccupied space of the housing structure 6312, for exampleto store a battery, microchip, or other opaque piece of technology thatis desirably held outside of the visual axis or pupillary aperture. Theopenings 6326A1, 6326B1, 6326C1, 6326D1, 6326A2, 6326B2, 6326C2, 6326D2may provide an anchor point, for example interacting with a protrusion,for another device to be held in the capsule of the device 6300 oroutside the device 6300. The openings 6326A1, 6326B1, 6326C1, 6326D1,6326A2, 6326B2, 6326C2, 6326D2 may be formed during formation of thehousing structure 6312 (e.g., as part of a molding process) and/orformed after formation of the housing structure 6212 (e.g., by a laser,chemical, or mechanical removal process). In some implementations, thehousing structure 6312 may comprise a different material around theopenings 6326A1, 6326B1, 6326C1, 6326D1, 6326A2, 6326B2, 6326C2, 6326D2(e.g., the housing structure 6312 comprising silicone and the openingsurrounding material comprising polyimide). In some implementations, thehousing structure 6312 may comprise thicker material around the openings6326A1, 6326B1, 6326C1, 6326D1, 6326A2, 6326B2, 6326C2, 6326D2 (e.g., tobuttress the openings 6326A1, 6326B1, 6326C1, 6326D1, 6326A2, 6326B2,6326C2, 6326D2, for example if another device is to be anchored to theopening 6326A1, 6326B1, 6326C1, 6326D1, 6326A2, 6326B2, 6326C2, 6326D2).In some implementations, the housing structure 6312 may comprise thinnermaterial around the openings 6326A1, 6326B1, 6326C1, 6326D1, 6326A2,6326B2, 6326C2, 6326D2 (e.g., for easier removal of material and/oropening formation).

FIG. 64A illustrates an anterior side perspective view of an exampleprosthetic capsular device 6400. FIG. 64B illustrates an anterior planview of the example prosthetic capsular device 6400 of FIG. 64A. FIG.64C illustrates a side view of the example prosthetic capsular device6400 of FIG. 64A. The device 6400 comprises openings 6426A, 6426B,6426C, 6426D in the housing structure 6412. Each of the openings 6426A,6426B, 6426C, 6426D may be the same as the others of the openings 6426A,6426B, 6426C, 6426D. At least one of the openings 6426A, 6426B, 6426C,6426D may be different than at least one of the other openings 6426A,6426B, 6426C, 6426D. The openings 6426A, 6426B, 6426C, 6426D, which aresmaller than the openings 6126A, 6126B described above, may increase thestructural integrity of the device 6400 and/or inhibit lens epithelialcell growth into the cavity of the housing structure 6412. The openings6426A, 6426B, 6426C, 6426D may allow delivery of a medicament from aninserted drug delivery platform through one, some, or all of theopenings 6426A, 6426B, 6426C, 6426D into the natural capsular bag andinto the vitreous or posterior segment. The openings 6426A, 6426B,6426C, 6426D may provide access the unoccupied space of the housingstructure 6412, for example to store a battery, microchip, or otheropaque piece of technology that is desirably held outside of the visualaxis or pupillary aperture. The openings 6426A, 6426B, 6426C, 6426D mayprovide an anchor point, for example interacting with a protrusion, foranother device to be held in the capsule of the device 6500 or outsidethe device 6500. The openings 6426A, 6426B, 6426C, 6426D illustrated inFIGS. 64A-64C are anterior to the ring structure portions 6420A, 6420B,6420C, 6420D, respectively. In some implementations, the openings 6426A,6426B, 6426C, 6426D may provide access from an anterior incision. Otherpositions, quantities, and shapes of the openings are also possible. Forexample, the device 6400 may comprise only one opening or more than fouropenings. The openings 6426A, 6426B, 6426C, 6426D may be at a positionother than anterior to the ring structure portions 6420A, 6420B, 6420C,6420D. The device 6400 may comprise a plurality of openings anterior tothe ring structure portions 6420A, 6420B, 6420C, 6420D or in anotherposition. The openings 6426A, 6426B, 6426C, 6426D are illustrated asbeing mirror-image circular openings, but other shapes are also possible(e.g., polygonal (e.g., rectangular), arcuate (e.g., circular,ellipsoid, oval), slits, combinations thereof, and the like). In someimplementations, the posterior surface of the device 6400 includes anopening that is longitudinally aligned with one, some, or all of theopenings 6426A, 6426B, 6426C, 6426D (e.g., the opening 6426E illustratedin FIG. 64A).

In some implementations, the opening 6426E and other such openings canprovide one or more advantages. The opening 6426E may inhibit or prevententrapment of fluid or potentially residual viscoelastic material afterimplantation of the device 6400, for example by allowinganterior-posterior fluid flow. The opening 6426E may allow a drugcontained in the device 6400 to reach a posterior segment of the eye(e.g., vitreous, retina, choroid). The opening 6426E may allow a slowrelease anti-VEGF injectable (e.g., ranibizuman (e.g., Lucentis® fromGenentech), aflibercept (e.g., Eylea® from Regerneron Pharmacueticals)or anti-VEGF produced from cells (e.g., from Neurotech) contained in thedevice 6400 to reach a posterior segment of the eye (e.g., vitreous,retina, choroid) for treatment of macular degeneration. The opening6426E may be sized such that there is little or no pressure gradientfrom posterior to anterior, for example during anterior decompression.In some implementations, the posterior portion of the natural capsularbag may be opened at a point corresponding to the opening 6426E tofacilitate the communication of the posterior segment with the anteriorsegment to aid in the diffusion of pharmaceutical agents. The opening ofthe capsule and the opening 6426E may be small enough in size that thereis a low likelihood of vitreous prolapse through the openings 6426E.

The openings 6426A, 6426B, 6426C, 6426D may be formed during formationof the housing structure 6412 (e.g., as part of a molding process)and/or formed after formation of the housing structure 6412 (e.g., by alaser, chemical, or mechanical removal process). In someimplementations, the housing structure 6412 may comprise a differentmaterial around the openings 6426A, 6426B, 6426C, 6426D (e.g., thehousing structure 6412 comprising silicone and the opening surroundingmaterial comprising polyimide). In some implementations, the housingstructure 6412 may comprise thicker material around the openings 6426A,6426B, 6426C, 6426D (e.g., to buttress the openings 6426A, 6426B, 6426C,6426D, for example if another device is to be anchored to the opening6426A, 6426B, 6426C, 6426D). In some implementations, the housingstructure 6412 may comprise thinner material around the openings 6426A,6426B, 6426C, 6426D (e.g., for easier removal of material and/or openingformation).

FIG. 65A illustrates an anterior side perspective view of an exampleprosthetic capsular device 6500. FIG. 65B illustrates an anterior planview of the example prosthetic capsular device 6500 of FIG. 65A. FIG.65C illustrates a side view of the example prosthetic capsular device6500 of FIG. 65A. The device 6500 comprises slots or slits 6526A1,6526B1, 6526C1, 6526D1, 6526A2, 6526B2, 6526C2, 6526D2 in the housingstructure 6512. When the device 6500 in in an unfolded state, the slits6526A1, 6526B1, 6526C1, 6526D1, 6526A2, 6526B2, 6526C2, 6526D2 maygenerally be in a closed unless acted upon. For example, pressure (e.g.,physical pressure such as from a device to be inserted therethrough,fluid pressure) applied to a slit can force the slit open. For anotherexample, the slits may allow the flow of small amounts of drug,proteins, fluid, etc. The slits 6526A1, 6526B1, 6526C1, 6526D1, 6526A2,6526B2, 6526C2, 6526D2 may be opened by applying opposing forces, forexample like a squeeze coin holder.

The slits 6526A1, 6526B1, 6526C1, 6526D1 illustrated in FIGS. 65A-65Care posterior to the ring structure portions 6520A, 6520B, 6520C, 6520D.The slits 6526A2, 6526B2, 6526C2, 6526D2 illustrated in FIGS. 65A-65Care anterior to the ring structure portions 6520A, 6520B, 6520C, 6520D.The slits 6526A1, 6526A2, 6526C1, 6526C2 illustrated in FIGS. 65A-65Care circumferentially between the ring structure portions 6520A, 6520C.The slits 6526B1, 6526B2, 6526D1, 6526D2 illustrated in FIGS. 65A-65Care circumferentially between the ring structure portions 6520B, 6520D.Other positions, quantities, and shapes of the slits are also possible.For example, the device 6500 may comprise only one slit, only two slits,only three slits, only four slits, only five slits, only six slits, onlyseven slits, only eight slits, or more than eight slits. The slits6526A1, 6526B1, 6526C1, 6526D1 may be at a position other than posteriorto the ring structure portions 6520A, 6520B, 6520C, 6520D. The slits6526A2, 6526B2, 6526C2, 6526D2 may be at a position other than anteriorto the ring structure portions 6520A, 6520B, 6520C, 6520D. The device6500 may comprise a plurality of slits posterior to the ring structureportions 6520A, 6520B, 6520C, 6520D, a plurality of slits anterior tothe ring structure portions 6520A, 6520B, 6520C, 6520D, or in anotherposition. The slits 6526A1, 6526B1, 6526C1, 6526D1 and the slits 6526A2,6526B2, 6526C2, 6526D1 are each illustrated as being mirror-imagestraight slits, but other shapes are also possible (e.g., polygonal,arcuate, combinations thereof, and the like). Each of the slits 6526A1,6526B1, 6526C1, 6526D1, 6526A2, 6526B2, 6526C2, 6526D2 may be the sameas the others of the slits 6526A1, 6526B1, 6526C1, 6526D1, 6526A2,6526B2, 6526C2, 6526D2. At least one of the slits 6526A1, 6526B1,6526C1, 6526D1, 6526A2, 6526B2, 6526C2, 6526D2 may be different than atleast one of the other slits 6526A1, 6526B1, 6526C1, 6526D1, 6526A2,6526B2, 6526C2, 6526D2. The slits 6526A1, 6526B1, 6526C1, 6526D1,6526A2, 6526B2, 6526C2, 6526D2, which are smaller than the slits 6126A,6126B described above, may increase the structural integrity of thedevice 6500 and/or inhibit lens epithelial cell growth into the cavityof the housing structure 6512. The slits 6526A1, 6526B1, 6526C1, 6526D1,6526A2, 6526B2, 6526C2, 6526D2 may allow delivery of a medicament froman inserted drug delivery platform through one, some, or all of theslits 6526A1, 6526B1, 6526C1, 6526D1, 6526A2, 6526B2, 6526C2, 6526D2into the natural capsular bag and into the vitreous or posteriorsegment. The slits 6526A1, 6526B1, 6526C1, 6526D1, 6526A2, 6526B2,6526C2, 6526D2 may provide access the unoccupied space of the housingstructure 6512, for example to store a battery, microchip, or otheropaque piece of technology that is desirably held outside of the visualaxis or pupillary aperture. The slits 6526A1, 6526B1, 6526C1, 6526D1,6526A2, 6526B2, 6526C2, 6526D2 may provide an anchor point, for exampleinteracting with a protrusion, for another device to be held in thecapsule of the device 6500 or outside the device 6500. The slits 6526A1,6526B1, 6526C1, 6526D1, 6526A2, 6526B2, 6526C2, 6526D2 may be formedduring formation of the housing structure 6512 (e.g., as part of amolding process) and/or formed after formation of the housing structure6512 (e.g., by a laser, chemical, or mechanical removal process). Insome implementations, the housing structure 6512 may comprise adifferent material around the slits 6526A1, 6526B1, 6526C1, 6526D1,6526A2, 6526B2, 6526C2, 6526D2 (e.g., the housing structure 6512comprising silicone and the opening surrounding material comprisingpolyimide). In some implementations, the housing structure 6512 maycomprise thicker material around the slits 6526A1, 6526B1, 6526C1,6526D1, 6526A2, 6526B2, 6526C2, 6526D2 (e.g., to buttress the slits6526A1, 6526B1, 6526C1, 6526D1, 6526A2, 6526B2, 6526C2, 6526D2, forexample if another device is to be anchored to the slits 6526A1, 6526B1,6526C1, 6526D1, 6526A2, 6526B2, 6526C2, 6526D2). In someimplementations, the housing structure 6512 may comprise thinnermaterial around the slits 6526A1, 6526B1, 6526C1, 6526D1, 6526A2,6526B2, 6526C2, 6526D2 (e.g., for easier removal of material, slitformation, slit opening, etc.).

FIG. 66A illustrates an anterior side perspective view of an exampleprosthetic capsular device 6600. FIG. 66B illustrates an anterior planview of the example prosthetic capsular device 6600 of FIG. 66A. FIG.66C illustrates a side view of the example prosthetic capsular device6600 of FIG. 66A. The device 6600 comprises slits 6626A1, 6626B1,6626C1, 6626D1, 6626A2, 6626B2, 6626C2, 6626D2 in the housing structure6612. The slits 6626A1, 6626B1, 6626C1, 6626D1 illustrated in FIGS.66A-66C are posterior to the ring structure portions 6620A, 6620B,6620C, 6620D. The slits 6626A2, 6626B2, 6626C2, 6626D2 illustrated inFIGS. 66A-66C are anterior to the ring structure portions 6620A, 6620B,6620C, 6620D. The slits 6626A1, 6626A2, 6626B1, 6626B2, 6626C1, 6626C2,6626D1, 6626D2 illustrated in FIGS. 66A-66C are circumferentiallyproximate to the anchor portions of the ring structure portions 6620A,6620B, 6620C, 6620D, respectively. Other positions, quantities, andshapes of the slits are also possible. For example, the device 6600 maycomprise only one slit, only two slits, only three slits, only fourslits, only five slits, only six slits, only seven slits, only eightslits, or more than eight slits. The slits 6626A1, 6626B1, 6626C1,6626D1 may be at a position other than posterior to the ring structureportions 6620A, 6620B, 6620C, 6620D. The slits 6626A2, 6626B2, 6626C2,6626D2 may be at a position other than anterior to the ring structureportions 6620A, 6620B, 6620C, 6620D. The device 6600 may comprise aplurality of slits posterior to the ring structure portions 6620A,6620B, 6620C, 6620D, a plurality of slits anterior to the ring structureportions 6620A, 6620B, 6620C, 6620D, or in another position. The slits6626A1, 6626B1, 6626C1, 6626D1 and the slits 6626A2, 6626B2, 6626C2,6626D1 are each illustrated as being mirror-image slits, but othershapes are also possible (e.g., polygonal, arcuate, combinationsthereof, and the like). Each of the slits 6626A1, 6626B1, 6626C1,6626D1, 6626A2, 6626B2, 6626C2, 6626D2 may be the same as the others ofthe slits 6626A1, 6626B1, 6626C1, 6626D1, 6626A2, 6626B2, 6626C2,6626D2. At least one of the slits 6626A1, 6626B1, 6626C1, 6626D1,6626A2, 6626B2, 6626C2, 6626D2 may be different than at least one of theother slits 6626A1, 6626B1, 6626C1, 6626D1, 6626A2, 6626B2, 6626C2,6626D2. The slits 6626A1, 6626B1, 6626C1, 6626D1, 6626A2, 6626B2,6626C2, 6626D2, which are smaller than the slits 6126A, 6126B describedabove, may increase the structural integrity of the device 6600 and/orinhibit lens epithelial cell growth into the cavity of the housingstructure 6612. The slits 6626A1, 6626B1, 6626C1, 6626D1, 6626A2,6626B2, 6626C2, 6626D2 may allow delivery of a medicament from aninserted drug delivery platform through one, some, or all of the slits6626A1, 6626B1, 6626C1, 6626D1, 6626A2, 6626B2, 6626C2, 6626D2 into thenatural capsular bag and into the vitreous or posterior segment. Theslits 6626A1, 6626B1, 6626C1, 6626D1, 6626A2, 6626B2, 6626C2, 6626D2 mayprovide access the unoccupied space of the housing structure 6612, forexample to store a battery, microchip, or other opaque piece oftechnology that is desirably held outside of the visual axis orpupillary aperture. The slits 6626A1, 6626B1, 6626C1, 6626D1, 6626A2,6626B2, 6626C2, 6626D2 may provide an anchor point, for exampleinteracting with a protrusion, for another device to be held in thecapsule of the device 6600 or outside the device 6600. The slits 6626A1,6626B1, 6626C1, 6626D1, 6626A2, 6626B2, 6626C2, 6626D2 may be formedduring formation of the housing structure 6612 (e.g., as part of amolding process) and/or formed after formation of the housing structure6612 (e.g., by a laser, chemical, or mechanical removal process). Insome implementations, the housing structure 6612 may comprise adifferent material around the slits 6626A1, 6626B1, 6626C1, 6626D1,6626A2, 6626B2, 6626C2, 6626D2 (e.g., the housing structure 6612comprising silicone and the slit surrounding material comprisingpolyimide). In some implementations, the housing structure 6612 maycomprise thicker material around the slits 6626A1, 6626B1, 6626C1,6626D1, 6626A2, 6626B2, 6626C2, 6626D2 (e.g., to buttress the slits6626A1, 6626B1, 6626C1, 6626D1, 6626A2, 6626B2, 6626C2, 6626D2, forexample if another device is to be anchored to the slits 6626A1, 6626B1,6626C1, 6626D1, 6626A2, 6626B2, 6626C2, 6626D2). In someimplementations, the housing structure 6612 may comprise thinnermaterial around the slits 6626A1, 6626B1, 6626C1, 6626D1, 6626A2,6626B2, 6626C2, 6626D2 (e.g., for easier removal of material, slitformation, slit opening, etc.).

The housing structure openings and slits described herein can be used toprovide an anchor point, a pathway through the housing structure (e.g.,for wires or leads from a battery exterior to the device to electronicsinside the device), for other device(s) to be held in the capsule of thedevice or outside the device. The other devices can include electronicdevices, medicament delivery systems, etc. In some implementations, thedevice comprises one or more interior and/or exterior protrusionsconfigured to interact with an element of another device.

FIG. 67A illustrates an anterior side perspective view of an exampleprosthetic capsular device 6700. FIG. 67B illustrates an anterior planview of the example prosthetic capsular device 6700 of FIG. 67A. FIG.67C illustrates a side view of the example prosthetic capsular device6700 of FIG. 67A. The device 6700 comprises ring structure portions6720A, 6720B, 6720C, 6720D. The ring structure portions 6720A, 6720B,6720C, 6720D comprise openings 6728A1, 6728B1, 6728C1, 6727D1,respectively, which may provide one or more of the advantages discussedherein with respect to openings of other ring structure portions. Thedevice 6700 further comprises openings or eyelets or grommets 6628A2,6628B2, 6628C2, 6628D2, 6628A3, 6628B3, 6628C3, 6628D3. The openings6628A2, 6628B2, 6628C2, 6628D2 are radially outward of and coupled tothe ring structure portions 6720A, 6720B, 6720C, 6720D, respectively.The openings 6628A2, 6628B2, 6628C2, 6628D2 are radially inward of andseparate from the ring structure portions 6720A, 6720B, 6720C, 6720D,respectively. Other positions, quantities, and shapes of the openingsare also possible. For example, the device 6700 may comprise only oneopening, only two openings, only three openings, only four openings,only five openings, only six openings, only seven openings, only eightopenings, only nine openings, only ten openings, only eleven openings,only twelve openings, or more than twelve openings. Each of the openings6728A1, 6728B1, 6728C1, 6728D1, 6728A2, 6728B2, 6728C2, 6728D2, 6728A3,6728B3, 6728C3, 6728D3 may be the same as the others of the openings6728A1, 6728B1, 6728C1, 6728D1, 6728A2, 6728B2, 6728C2, 6728D2, 6728A3,6728B3, 6728C3, 6728D3. At least one of the openings 6728A1, 6728B1,6728C1, 6728D1, 6728A2, 6728B2, 6728C2, 6728D2, 6728A3, 6728B3, 6728C3,6728D3 may be different than at least one of the other openings 6728A1,6728B1, 6728C1, 6728D1, 6728A2, 6728B2, 6728C2, 6728D2, 6728A3, 6728B3,6728C3, 6728D3. The openings 6728A1, 6728B1, 6728C1, 6728D1, 6728A2,6728B2, 6728C2, 6728D2, 6728A3, 6728B3, 6728C3, 6728D3 may provide ananchor point, for example interacting with a protrusion, for anotherdevice to be held outside the device 6700, for suturing to parts of aneye such as a natural capsular bag, zonules, ciliary muscles, scleralwall, etc., and/or for allowing epithelial cell growth, allow fibrosistherethrough, and/or the like. Other devices can be coupled to one ormore of the openings 6728A1, 6728B1, 6728C1, 6728D1, 6728A2, 6728B2,6728C2, 6728D2, 6728A3, 6728B3, 6728C3, 6728D3 after the device 6700 hasbeen positioned in a natural capsular bag of an eye. Coupling the otherdevice(s) after positioning of the device 6700, for example as opposedto coupling or integrally forming the other device(s) to the device 6700before positioning the device 6700 in an eye, can allow the device 6700to be injected through a smaller opening as described herein. Couplingother device(s), for example as opposed to coupling or integrallyforming the other device(s) with the device 6700, can allow a variety ofother devices to be used. In some implementations, the other device(s)may be removed and a replacement or other device may optionally becoupled during a later procedure. In some implementations, the otherdevice(s) may be absorbed over time, and a replacement or other devicemay optionally be coupled during a later procedure. The positions of theopenings 6728A1, 6728B1, 6728C1, 6728D1, 6728A2, 6728B2, 6728C2, 6728D2,6728A3, 6728B3, 6728C3, 6728D3 can allow functional use of other devicesin the volume of the natural capsular bag radially outward of thehousing structure 6812. The openings 6728A1, 6728B1, 6728C1, 6728D1,6728A2, 6728B2, 6728C2, 6728D2, 6728A3, 6728B3, 6728C3, 6728D3 may beformed during formation of the device 6700 (e.g., as part of a moldingprocess) and/or formed after formation of the device 6700 (e.g., by alaser, chemical, or mechanical removal process). In someimplementations, the housing structure 6712 may comprise a differentmaterial than the material surrounding the openings 6728A1, 6728B1,6728C1, 6728D1, 6728A2, 6728B2, 6728C2, 6728D2, 6728A3, 6728B3, 6728C3,6728D3 (e.g., the housing structure 6712 comprising silicone and theopening surrounding material comprising polyimide).

FIG. 78A illustrates an anterior side perspective view of an example ofa prosthetic capsular device 7800. FIG. 78B illustrates an anterior planview of the example prosthetic capsular device 7800 of FIG. 78A. FIG.78C illustrates a cross-sectional view of the example prostheticcapsular device 7800 of FIG. 78A along the line 78C-78C of FIG. 78B. Insome embodiments, the device 7800 includes features described withrespect to the device 5800 or modifications thereof. For example, thedevice 7800 can comprise an anterior side 7802, a posterior side 7804,and sidewalls 7806 extending between the anterior side 7802 and theposterior side 7804; the anterior side 7802 comprises an opening 7808;the posterior side 7804 optionally comprises a refractive surface 7810;the prosthetic device 7800 comprises a ring structure 7820 (e.g.,comprising ring structure portions 7820A, 7820B, 7820C, 7820D) coupledto a housing structure 7812 comprising the anterior side 7802, posteriorside 7804, and sidewalls 7806; and the ring portions 7820A, 7820B,7820C, 7820D comprising aperture sections 7827 comprising holes orapertures or openings or eyelets 7828.

The device 7800 comprises openings 7826A, 7826B in the posterior wall ofthe housing structure 7812. The openings 7826A, 7826B can be locatedradially outward of a refractive surface of the posterior wall or end ofthe device 7800. Each of the openings 7826A, 7826B may be the same asthe others of the openings 7826A, 7826B. For example, each of theopenings 7826A, 7826B can have the same shape, curvature, length, and/orwidth. At least one of the openings 7826A, 7826B may be different thanat least one of the other openings 7826A, 7826B. For example, at leastone of the openings 7826A, 7826B can have a different shape, curvature,length, and/or width from at least one of the other openings 7826A,7826B. The openings 7826A, 7826B may inhibit or prevent entrapment offluid or potentially residual viscoelastic material after implantationof the device 7800, for example by allowing anterior-posterior fluidflow along with the anterior opening 7808.

The openings 7826A, 7826B may allow fluid and/or solute, for exampledrugs, to equilibrate into the anterior and/or posterior segments of theeye. Without the openings 7826A, 7826B, the posterior wall couldpotentially be a barrier for equilibrium to occur. Accordingly, theopenings 7826A, 7826B may allow a drug or a slow-release drug placedinside the housing structure 7812 to reach the posterior segment of theeye, such as the retina, choroid, RPE, or the like. This can beparticularly advantageous for certain drugs or slow-release drugs thathave a therapeutic target in the posterior segment of the eye, such asUvea, Choroid, Retina, Retinal Pigment Epithelium, or the like. Further,the openings 7826A, 7826B may facilitate to keep the fluid pressureinside the housing structure 7812 at an acceptable level that does notrisk the integrity of the housing structure 7812.

In some embodiments, the openings 7826A, 7826B can be configured topassively facilitate or allow fluid and/or solute flow from and/or tothe interior of the housing structure 7812. Accordingly, if fluid,oncotic and/or osmotic gradient pressure inside the housing structure7812 is higher than that in the posterior capsule, fluid can be allowedto flow passively through one or more of the anterior openings 7826A,7826B from the interior of the housing structure 7812 to the posteriorcapsule. Similarly, if fluid, oncotic and/or osmotic gradient pressureinside the housing structure 7812 is lower than that in the posteriorcapsule, fluid can be allowed to flow passively through one or more ofthe anterior openings 7826A, 7826B from the posterior capsule into theinterior of the housing structure 7812.

In certain embodiments, one or more of the anterior openings 7826A,7826B can be configured to actively facilitate fluid flow, for exampleby use in conjunction with one or more sensors and/or fluid pumps. Inparticular, when the fluid, oncotic and/or osmotic gradient pressureinside the housing structure 7812 is above a predetermined level, asdetected by a sensor inside the housing structure 7812 for example, acomputer processor or the like can be configured to automaticallyactivate a pump or micro pump to actively facilitate fluid flow from theinterior of the housing structure 7812 to the posterior capsule or otherlocation exterior to the housing structure 7812 through the one or moreanterior openings 7826A, 7826B.

The openings 7826A, 7826B may be formed during formation of the housingstructure 7812 (e.g., as part of a molding process) and/or formed afterformation of the housing structure 7812 (e.g., by a laser, chemical, ormechanical removal process). In some implementations, the housingstructure 7812 may comprise a different material around the openings7826A, 7826B (e.g., the housing structure 7812 comprising silicone andthe opening surrounding material comprising polyimide). In otherembodiments, the housing structure 7812 may comprise the same materialaround the openings 7826A, 7826B as other portions of the housingstructure 7812. In some implementations, the housing structure 7812 maycomprise thicker material around the openings 7826A, 7826B (e.g., tobuttress the openings 7826A, 7826B, for example if another device is tobe anchored to the openings 7826A, 7826B). In some implementations, thehousing structure 7812 may comprise thinner material around the openings7826A, 7826B (e.g., for easier removal of material and/or openingformation).

The openings 7826A, 7826B can allow evacuation of viscoelastic materialfrom behind the refractive surface 7810 and/or the posterior wall of thehousing structure 7812. The openings 7826A, 7826B can provide access tothe posterior capsule. For example, if a primary posterior capsulotomywas created (e.g., using a femtosecond laser after implantation of thedevice 7800), the openings 7826A, 7826B could allow use of forceps tograb a cut posterior capsulorhexis and remove it from the eye. Openings7826A, 7826B on each side of the refractive surface 7810 may allow therefractive surface 7810 to tilt (e.g., along the major axis if theopenings 7826A, 7826B are on opposite sides of the major axis), whichmay allow greater access to an area posterior to the refractive surface7810. Similarly, the openings 7826A, 7826B can allow fluid flow from theposterior capsule to the interior of the housing structure 7812.

The openings 7826A, 7826B can hold or otherwise interact with a drugeluting device. The openings 7826A, 7826B can allow a medicament accessto the posterior capsule (e.g., for treatment of retinal and/or uvealdiseases). The openings 7826A, 7826B may allow a drug contained in thedevice 7800 to reach a posterior segment of the eye (e.g., vitreous,retina, choroid). The openings 7826A, 7826B may allow a slow releaseanti-VEGF injectable (e.g., ranibizuman (e.g., Lucentis® fromGenentech), aflibercept (e.g., Eylea® from Regerneron Pharmacueticals)or anti-VEGF produced from cells (e.g., from Neurotech) contained in thedevice 7800 to reach a posterior segment of the eye (e.g., vitreous,retina, choroid) for treatment of macular degeneration. The openings7826A, 7826B may provide controlled fluid flow between the interior ofthe housing structure 7812 and the posterior capsule. For example, thesize or width of one or more openings 7826A, 7826B can be controlled tofacilitate and/or prevent fluid flow between the interior of the housingstructure 7812 and the posterior capsule. Additionally, and/oralternatively, one or more pumps or micro pumps can be utilized tocontrol the level of fluid flow between the interior of the housingstructure 7812 and the posterior capsule.

The refractive surface 7810 may have a diameter between about 4 mm andabout 9 mm (e.g., about 4 mm, about 5 mm, about 6 mm, about 7 mm, about8 mm, about 9 mm, ranges between such values, etc.). In someembodiments, the openings 7826A, 7826B are spaced from the outercircumference of the refractive surface 7810 by between about 0.2 mm andabout 1 mm (e.g., about 0.2 mm, about 0.3 mm, about 0.4 mm, about 0.5mm, about 0.6 mm, about 0.7 mm, about 0.8 mm, about 0.9 mm, about 1 mm,ranges between such values, etc.). In some embodiments, the openings7826A, 7826B comprise arcs of a circle having a diameter 7830 betweenabout 4.5 mm and about 9.5 mm (e.g., about 4.5 mm, about 5.5 mm, about4.5 mm, about 4.5 mm, about 4.5 mm, about 9.5 mm, ranges between suchvalues, etc.). For example, if the refractive surface 7810 has adiameter of 5 mm and the openings 7826A, 7826B are spaced radiallyoutward from the outer circumference of the refractive surface 7810 by0.5 mm, the openings 7826A, 7826B would have a diameter 7830 of 5.5 mm.

The outer or under certain circumstances maximum diameter 7832 of thedevice 7800, for example accounting for extension of the ring structure7820, may be between about 9 mm and about 12 mm (e.g., about 9 mm, about9.5 mm, about 10 mm, about 10.3 mm, about 10.5 mm, about 11 mm, about 12mm, ranges between such values, etc.). The housing structure 7812 mayhave the same dimensions as the housing structure 5812 of the device5800.

The openings 7826A, 7826B may have a thickness or width 7834 betweenabout 0 mm (e.g., being slits as described with to FIG. 78F) and about0.5 mm (e.g., about 0 mm, about 0.1 mm, about 0.2 mm, about 0.3 mm,about 0.4 mm, about 0.5 mm, ranges between such values, etc.). In someembodiments, the openings 7826A, 7826B are sized such that there islittle or no pressure gradient from posterior to anterior, for exampleduring anterior decompression. The openings 7826A, 7826B may be smallenough in size that there is a low likelihood of vitreous prolapsethrough the openings 7826A, 7826B.

In some embodiments, the thickness or width of the openings 7826A, 7826Bis uniform throughout the length of the openings 7826A, 7826B. In otherembodiments, the thickness or width of the openings 7826A, 7826B is notuniform throughout the length of the openings 7826A, 7826B. For example,a terminal portion(s) or central portion of the openings 7826A, 7826Bcan have a thicker or thinner width or thickness. Similarly, thethickness or width of one opening 7826A, 7826B can be thicker or thinnerthan the thickness or width of another opening 7826A, 7826B to betterfacilitate fluid flow through the thicker or wider opening 7826A, 7826B.For example, the thickness or width of a bottom opening 7826A, 7826B canbe wider or thicker than a top opening 7826A, 7826B to better facilitatefluid flow. In other embodiments, all openings 7826A, 7826B can comprisethe same thickness of width.

In some embodiments, the openings 7826A, 7826B comprise arcs of acircle. One or more of the openings 7826A, 7826B may comprise acircumferential angle between about 30° and about 120° (e.g., about 30°,about 45°, about 60°, about 75°, about 90°, about 105°, about 120°,ranges between such values, etc.). Similarly, one or more of theopenings 7826A, 7826B may comprise a circumferential angle of about 15°,about 130°, about 145°, about 160°, about 170°, and/or within a rangedefined by two of the aforementioned values. The openings 7826A, 7826Bare illustrated as being mirror-image circular arc openings, but othershapes are also possible (e.g., polygonal (e.g., rectangular), arcuate(e.g., circular, ellipsoid, oval), slits, combinations thereof, and thelike).

In some embodiments, the device 7800 comprises a bulge 7816. In someembodiments, the bulge 7816 extends radially outward of the sidewalls7806 (e.g., as shown in FIGS. 78A and 78B). In some embodiments, thebulge 7816 extends radially inward of the sidewalls 7806. In someembodiments, the bulge 7816 extends radially inward and radially outwardof the sidewalls 7806. The device 7800 includes a bulge 7816 on each endportion. In some embodiments, the bulge 7816 can be limited to portionsaround ring structure portion anchors. The housing structure 7812 maycomprise the bulge 7816 (e.g., the bulge 7816 being integral with thehousing structure 7812). In some implementations, the ring structure7820 is placed in a mold and the housing structure 7812 is overmoldedaround the ring structure 7820. The bulge 7816 may be coupled to thehousing structure 7812. The bulge 7816 may comprise the same material asthe housing structure 7812 or a different material than the housingstructure 7812. The bulge 7816 may allow the anchors to be substantiallyradially aligned with, radially outward of, or radially inward of thesidewalls 7806. The bulge 7816 may provide extra material in which thering structure 7820 may anchor, for example maintaining a wall thickness(e.g., about 0.2 mm) on one or both sides of the ring structure 7820with or without the use of a primer. The bulge 7816 may allow thematerial of the housing structure 7812 to surround (e.g., completelysurround) the anchoring portions of the ring structure portion 7820,which can avoid an area of weakness and/or discontinuity of the housingstructure 7812. The device 7800 includes bulges 7816 that extend alongthe entire edge portions of the housing structure 7812, even beyond thetermination of the anchor portions. In some implementations, the deviceincludes bulges 7816 that extend slightly beyond the termination of theanchor portions.

The device 7800 optionally comprises a posterior fin 7824. The device7800 shown includes two posterior fins 7824. The posterior fins 7824 arealigned along a diameter of the refractive surface 7810 and in line withthe major axis of the prosthetic device 7800. In some implementations, aplurality of posterior fins 7824 (e.g., 2, 3, 4, 5, 6, or more fins7824) may be circumferentially offset (e.g., by about 180°, by about120°, by about 90°, by about 72°, by about 60°, and the like). In someimplementations, at least some or all of a plurality of posterior fins7824 (e.g., 2, 3, 4, 5, 6, or more fins 7824) may be unaligned. Theposterior fins 7824 are aligned along a major axis of the device 7800.In some implementations, the posterior fins 7824 may be aligned along aminor axis of the device 7800. In some implementations, the posteriorfins 7824 may be unaligned along an axis of the device 7800 (e.g., at anangle with respect to the major axis and/or the minor axis). The housingstructure 7812 may comprise the posterior fin 7824 (e.g., the posteriorfin 7824 being integral with the housing structure 7812). The posteriorfin 7824 may be coupled to the housing structure 7812. The posterior fin7824 may comprise the same material as the housing structure 7812 or adifferent material than the housing structure 7812. The posterior fin7824 may help to space a posterior surface of a natural capsular bagfrom the posterior end 7804 of the housing structure 7812 radiallyoutward of the refractive surface 7810. Spacing the posterior surface ofthe natural capsular bag from the posterior end 7804 of the housingstructure 7812 radially outward of the refractive surface 7810 may allowfluid flow radially outward of the refractive surface 7810, which mayhelp to reduce opacification. Spacing the posterior surface of thenatural capsular bag from the posterior end 7804 of the housingstructure 7812 radially outward of the refractive surface 7810 mayreduce the chance of retaining viscoelastic that has some residualtrapped fibrin or inflammatory precipitate contained within it. In someembodiments, the posterior fin 7824 may extend anterior from theposterior of the housing structure 7812 into the cavity of the housingstructure 7812. In some embodiments, the posterior fin comprises aroughened or opacified interior and/or exterior surface of the housingstructure 7812 (e.g., having the same thickness and material as theposterior wall radially outward of the refractive surface 7810 buttreated to provide an alignment mark).

In embodiments in which the fins 7824 are aligned with the major axis ofthe device 7800, the device 7800 can be strategically aligned in an eye.For example, if an eye has astigmatism, a device 7800 in which therefractive surface 7810 comprises a toric lens can be used to at leastpartially correct the astigmatism if the device 7800 is properlyoriented (e.g., with the steep axis of a cornea). In someimplementations, at least one of the fins 7824 can be different (e.g.,different shape, dimensions, etc.) to indicate a top or bottom of thedevice 7800. In devices allowing any rotational orientation of an IOLinserted therein, a toric IOL can be rotated. The device 7800 includestruncated sides, reducing volume and in some cases advantageouslylimiting rotation of an IOL inserted therein. Aligning the device 7800for alignment of a toric refractive surface 7810 and/or a toric IOLcontained in the device 7800 can advantageously provide the advantagesof limited IOL rotation, reduced volume, and astigmatism correction.

FIG. 78D is an anterior plan view of another example prosthetic capsulardevice 7850. In contrast to the device 7800, the device 7850 comprises asingle opening 7856A in the posterior wall of the housing structure7812. A single opening 7856A may provide many of the same functions oradvantages as a plurality of openings 7826A, 7826B described withrespect to the device 7800, for example allowing evacuation ofviscoelastic material from and/or to the posterior wall of the housingstructure 7812, providing access to the posterior capsule, allowinggrabbing of a cut posterior capsulorhexis, holding or otherwiseinteracting with a drug eluting device, allowing a medicament access tothe posterior capsule, etc.

In embodiments in which the opening 7856A is generally parallel to themajor axis of the device 7850, the device 7850 can be strategicallyaligned in an eye. For example, if an eye has astigmatism, a device 7850in which the refractive surface 7810 comprises a toric lens can be usedto at least partially correct the astigmatism if the device 7850 isproperly oriented (e.g., with the steep axis of a cornea). In someimplementations, at least one part of the opening 7856A can be different(e.g., different shape, dimensions, etc.) to indicate a top or bottom ofthe device 7850. In devices allowing any rotational orientation of anIOL inserted therein, a toric IOL can be rotated. The device 7850includes truncated sides, reducing volume and in some casesadvantageously limiting rotation of an IOL inserted therein. Aligningthe device 7850 for alignment of a toric refractive surface 7810 and/ora toric IOL contained in the device 7850 can advantageously provide theadvantages of limited IOL rotation, reduced volume, and astigmatismcorrection. In other embodiments, the device 7850 can comprise a singleopening 7856A positioned generally parallel to a minor axis of thedevice 7850.

FIG. 78E is an anterior plan view of yet another prosthetic capsulardevice 7860. In contrast to the device 7800, the device 7860 comprises afirst opening 7866A in the posterior wall of the housing structure 7812that crosses the major axis on a first side of the refractive surface7810 and a second opening 7866B in the posterior wall of the housingstructure 7812 that crosses the major axis on a second side of therefractive surface 7810 opposite the first side of the refractivesurface 7810. In embodiments in which the anterior opening is oblong,openings 7866A, 7866B crossing the major axis may be easier to accessthan openings crossing the minor axis. In other embodiments, the device7860 can comprise a first opening in the posterior wall of the housingstructure 7812 that crosses the minor axis on a first of the refractivesurface 7810 and a second opening in the posterior wall of the housingstructure 7812 that crosses the minor axis on a second side of therefractive surface 7810 opposite the first side of the refractivesurface 7810.

The openings 7866A, 7866B may provide many of the same functions oradvantages as a plurality of openings 7826A, 7826B described withrespect to the device 7800, for example allowing evacuation ofviscoelastic material from and/or to the posterior wall of the housingstructure 7812, providing access to the posterior capsule, allowinggrabbing of a cut posterior capsulorhexis, holding or otherwiseinteracting with a drug eluting device, allowing a medicament access tothe posterior capsule, etc. Openings 7866A, 7866B on each side of therefractive surface 7810 may allow the refractive surface 7810 to tilt(e.g., along the minor axis if the openings 7866A, 7866B are on oppositesides of the minor axis), which may allow greater access to an areaposterior to the refractive surface 7810. Similarly, openings 7866A,7866B on each side of the refractive surface 7810 on opposite sides ofthe major axis may allow the refractive surface 7810 to tilt along themajor axis.

FIG. 78F is an anterior plan view of still another prosthetic capsulardevice 7870. The device 7870 comprises a first slit 7876A in theposterior wall of the housing structure 7812 a second slit 7876B in theposterior wall of the housing structure 7812. In contrast to theopenings 7826A, 7826B of the device 7800, the slits 7876A, 7876B areconfigured to be in a closed position absent outside force. For example,pressure (e.g., physical pressure such as from a device to be insertedtherethrough, fluid pressure) applied to a slit 7876A, 7876B can forcethe slit 7876A, 7876B open. As such, a slit 7876A, 7876B can beconfigured to be opened to allow fluid flow therethrough when the fluid,oncotic, and/or osmotic gradient pressure is above a certain level. Theparticular level of fluid, oncotic, and/or osmotic gradient pressurethat would allow fluid flow through a slit 7876A, 7876B can becontrolled or predetermined by controlling the length and/or material ofthe slit 7876A, 7876B during the manufacturing process. The slits 7876A,7876B may also be opened by applying opposing forces, for example like asqueeze coin holder.

The housing structure 7812 may comprise a different material around theslits 7876A, 7876B. For example, the slit-surrounding material cancomprise a material that is more flexible than other portions of thehousing structure 7812 to facilitate fluid flow. In other embodiments,the housing structure 7812 may comprise the same material around theslits 7876A, 7876B as other portions of the housing structure 7812. Insome implementations, the housing structure 7812 may comprise thinnermaterial around the slits 7876A, 7876B, for example to facilitate fluidflow when the fluid pressure is at a relatively low predetermined level.In some implementations, the housing structure 7812 may comprise thickermaterial around the slits 7876A, 7876B, for example to allow fluid flowthrough the slits only when the fluid pressure is a relatively highpredetermined level and/or only when the integrity of the housingstructure 7812 is at risk due to the fluid pressure.

The slits 7876A, 7876B may provide many of the same functions oradvantages as a plurality of openings 7826A, 7826B described withrespect to the device 7800, for example allowing evacuation ofviscoelastic material from and/or to the posterior wall of the housingstructure 7812, providing access to the posterior capsule, allowinggrabbing of a cut posterior capsulorhexis, holding or otherwiseinteracting with a drug eluting device, allowing a medicament access tothe posterior capsule, etc. Slits 7876A, 7876B on each side of therefractive surface 7810 may allow the refractive surface 7810 to tilt(e.g., along the major axis if the openings 7876A, 7876B are on oppositesides of the major axis), which may allow greater access to an areaposterior to the refractive surface. Similarly, slits 7876A, 7876B oneach side of the refractive surface 7810 on opposite sides of the majoraxis may allow the refractive surface 7810 to tilt along the major axis.

Combinations of the devices 7800, 7850, 7860, 7870 and modificationsthereof are also possible. For example, a device may comprise a singleslit, which may be in the position of the opening 7866B. For anotherexample, a device may comprise a combination of the opening 7856A andthe slit 7876B. The device may comprise more than two slits or openings.

FIG. 79A is a top perspective view of an example embodiment of a ringstructure portion 7920. FIG. 79B is a left side view of the ringstructure portion 7920 of FIG. 79A. FIG. 79C is a right side view of thering structure portion 7920 of FIG. 79A. FIG. 79D is an upper end viewof the ring structure portion 7920 of FIG. 79A. FIG. 79E is a lower endview of the ring structure portion 7920 of FIG. 79A. FIG. 79F is a topplan view of the ring structure portion 7920 of FIG. 79A, the bottomplan view being a mirror image.

The ring structure portion 7920 comprises a first anchor portion 7922Aextending in a first direction, a second anchor portion 7922B extendingin a second direction at an angle to the first direction, and an arm7921. The first anchor portion 7922A and the second anchor portion 7922Bmay comprise the same or similar properties or at least one propertythat is different (e.g., material, composition, dimension,cross-sectional shape, combinations thereof, etc.). The anchors portions7922A, 7922B and the arm 7921 may comprise the same or similarproperties or at least one property that is different (e.g., material,composition, dimension, cross-sectional shape, combinations thereof,etc.). The anchor portions 7922A, 7922B may be at least partiallyembedded in a housing structure of a prosthetic capsular device. Incertain such embodiments, the device comprises a bulge at leastpartially around the anchor portions 7922A, 7922B.

The arm 7921 comprises an aperture section 7927 comprising an opening7928. The opening 7928 may extend partially or entirely through theaperture section 7927. In some embodiments (e.g., as illustrated in FIG.79A), the aperture section 7927 is at an end of the arm 7921. In someembodiments, the aperture section 7927 may be at a different locationalong the arm 7921 (e.g., proximate to the elbow, along an intermediatesegment, etc.). In some embodiments (e.g., as illustrated in FIG. 79A),the arm 7921 comprises a single aperture section 7927. In someembodiments, (e.g., with reference to FIG. 67A), the arm 7921 comprisesa plurality of aperture sections 7927. In some embodiments, (e.g., withreference to FIG. 67A), at least one of the anchor portions 7922A, 7922Bcomprises an aperture section 7927. The arm 7921 may have a singleradius of curvature, a plurality of radii of curvature, be straight,change direction, have an undulating or sinusoidal shape (e.g.,including alternating radially inward troughs and radially outward peaksor apices), and/or the like.

In some embodiments, a device comprises four ring structure portions7920. For example, with reference to the device 7800, the ring structureportion 7820D may be the ring portion structure 7920 in the orientationshown in FIG. 79F, the ring structure portion 7820C may be the ringportion structure 7920 flipped vertically from the orientation shown inFIG. 79F, the ring structure portion 7820B may be the ring portionstructure 7920 flipped vertically and horizontally from the orientationshown in FIG. 79F, and the ring structure portion 7820A may be the ringportion structure 7920 flipped horizontally from the orientation shownin FIG. 79F. In some embodiments, for example with reference to FIGS.58H-58L, a device may comprise fewer than four ring structure portions7920.

The ring structure portion 7920 can provide the same functions as otherring structure portions described herein, but the contours areornamental and aesthetically pleasing, for example because the linebetween the first anchor portion 7922A and the arm 7921 is smoother.

FIG. 80A is a top perspective view of an example embodiment of a ringstructure portion 8020. FIG. 80B is a left side view of the ringstructure portion 8020 of FIG. 80A. FIG. 80C is a right side view of thering structure portion 8020 of FIG. 80A. FIG. 80D is an upper end viewof the ring structure portion 8020 of FIG. 80A. FIG. 80E is a lower endview of the ring structure portion 8020 of FIG. 80A. FIG. 80F is a topplan view of the ring structure portion 8020 of FIG. 80A, the bottomplan view being a mirror image.

The ring structure portion 8020 comprises a first anchor portion 8022Aextending in a first direction, a second anchor portion 8022B extendingin a second direction at an angle to the first direction, and an arm8021. The first anchor portion 8022A and the second anchor portion 8022Bmay comprise the same or similar properties or at least one propertythat is different (e.g., material, composition, dimension,cross-sectional shape, combinations thereof, etc.). The anchors portions8022A, 8022B and the arm 8021 may comprise the same or similarproperties or at least one property that is different (e.g., material,composition, dimension, cross-sectional shape, combinations thereof,etc.). The anchor portions 8022A, 8022B may be at least partiallyembedded in a housing structure of a prosthetic capsular device. Incertain such embodiments, the device comprises a bulge at leastpartially around the anchor portions 8022A, 8022B.

The arm 8021 comprises an aperture section 8027 comprising an opening8028. The opening 8028 may extend partially or entirely through theaperture section 8027. In some embodiments (e.g., as illustrated in FIG.80A), the aperture section 8027 is at an end of the arm 8021. In someembodiments, the aperture section 8027 may be at a different locationalong the arm 8021 (e.g., proximate to the elbow, along an intermediatesegment, etc.). In some embodiments (e.g., as illustrated in FIG. 80A),the arm 8021 comprises a single aperture section 8027. In someembodiments, (e.g., with reference to FIG. 67A), the arm 8021 comprisesa plurality of aperture sections 8027. In some embodiments, (e.g., withreference to FIG. 67A), at least one of the anchor portions 8022A, 8022Bcomprises an aperture section 8027. The arm 8021 may have a singleradius of curvature, a plurality of radii of curvature, be straight,change direction, have an undulating or sinusoidal shape (e.g.,including alternating radially inward troughs and radially outward peaksor apices), and/or the like.

In some embodiments, a device comprises four ring structure portions8020. For example, with reference to the device 7800, the ring structureportion 7820D may be the ring portion structure 8020 in the orientationshown in FIG. 80F, the ring structure portion 7820C may be the ringportion structure 8020 flipped vertically from the orientation shown inFIG. 80F, the ring structure portion 7820B may be the ring portionstructure 8020 flipped vertically and horizontally from the orientationshown in FIG. 80F, and the ring structure portion 7820A may be the ringportion structure 8020 flipped horizontally from the orientation shownin FIG. 80F. In some embodiments, for example with reference to FIGS.58H-58L, a device may comprise fewer than four ring structure portions8020.

The ring structure portion 8020 can provide the same functions as otherring structure portions described herein, but the contours areornamental and aesthetically pleasing, for example because the linebetween the first anchor portion 8022A and the arm 8021 is smoother,even smoother than the line between the first anchor portion 7922A andthe arm 7921 of the ring structure portion 7920.

FIG. 68A illustrates an anterior side perspective view of an exampleprosthetic capsular device 6800. FIG. 68B illustrates an anterior planview of the example prosthetic capsular device 6800 of FIG. 68A. FIG.68C illustrates a side view of the example prosthetic capsular device6800 of FIG. 68A. The device 6800 comprises ring structure portions6820A, 6820B, 6820C, 6820D. The device 6800 further comprises a slidingretainer 6830A posterior to and circumferentially between the ringstructure portions 6820A, 6820B and a sliding retainer 6830B posteriorto and circumferentially between the ring structure portions 6820C,6820D. The sliding retainer 6830A comprises an upper or anterior portionand a lower or posterior portion forming a retaining cavity 6832A, andthe sliding retainer 6830B comprises an upper or anterior portion and alower or posterior portion forming a retaining cavity 6832B. Thepositions between the ring structure portions can allow functional useof other devices in the volume of the natural capsular bag radiallyoutward of the housing structure 6812. Other positions, quantities, andshapes of the sliding retainers are also possible. For example, thedevice 6800 may comprise only one sliding retainer, only two slidingretainers, or more than two sliding retainers. In some implementations,a sliding retainer comprises a dovetail-shaped retaining cavity, forexample configured to interact with a dovetail-shaped protrusion ofanother device.

The sliding retainers 6830A, 6830B are configured to receive a slotprotrusion of another device. For example, FIG. 68D schematically showsan example of another device 6850 interacting with the sliding retainer6830B. One or more devices may interact with one or both of the slidingretainers 6830A, 6830B (e.g., sliding in from one or either end of thesliding retainers 6830A, 6830B). The example device 6850 includes a slotprotrusion 6852 and a radially outwardly projecting part 6854. Theprojecting part 6854 may take any variety of shapes and sizes. Thedevice 6850 can be slid into the retaining cavity of the structure 6830Bafter the device 6800 has been positioned in a natural capsular bag ofan eye. Coupling the device 6850 after positioning of the device 6800,for example as opposed to coupling or integrally forming the device 6850to the device 6800 before positioning the device 6800 in an eye, canallow the device 6800 to be injected through a smaller opening asdescribed herein. Coupling the device 6850, for example as opposed tocoupling or integrally forming the device 6850 with the device 6800, canallow a variety of other devices 6850 to be used. In someimplementations, the other device may be removed (e.g., by sliding outthe side of the sliding retainer, by radially pulling out if the slidingretainer material is resilient, etc.) and a replacement or other devicemay optionally be coupled during a later procedure. In someimplementations, the other device may be absorbed over time, and areplacement or other device may optionally be coupled during a laterprocedure.

The sliding retainers 6830A, 6830B may be formed during formation of thedevice 6800 (e.g., as part of a molding process) and/or formed afterformation of the device 6800 (e.g., by a laser, chemical, or mechanicalremoval process). In some implementations, the housing structure 6812may comprise a different material than the sliding retainers 6830A,6830B (e.g., the housing structure 6812 comprising silicone and thesliding retainers 6830A, 6830B comprising polyimide). The slidingretainers 6830A, 6830B may be integral with or separate from the ringstructure portions 6820A, 6820B, 6820C, 6820D.

FIG. 69A illustrates an anterior side perspective view of an exampleprosthetic capsular device 6900. FIG. 69B illustrates an anterior planview of the example prosthetic capsular device 6900 of FIG. 69A. FIG.69C illustrates a side view of the example prosthetic capsular device6900 of FIG. 69A. The device 6900 comprises ring structure portions6920A, 6920B, 6920C, 6920D. The device 6900 further comprises a slidingretainer 6930A radially inward of and circumferentially between the ringstructure portions 6920A, 6920B and a sliding retainer 6930B radiallyinward of and circumferentially between the ring structure portions6920C, 6920D. The sliding retainer 6930A comprises a first portionradially inward of the ring structure portion 6920A and a second portionradially inward of the ring structure portion 6920B, the first portionand the second portion forming a retaining cavity 6932A. The slidingretainer 6930B comprises a first portion radially inward of the ringstructure portion 6920C and a second portion radially inward of the ringstructure portion 6920D, the first portion and the second portionforming a retaining cavity 6932B. The positions circumferentiallybetween the ring structure portions can allow functional use of otherdevices in the volume of the natural capsular bag radially outward ofthe housing structure 6912. Other positions, quantities, and shapes ofthe sliding retainers are also possible. For example, the device 6900may comprise only one sliding retainer, only two sliding retainers, ormore than two sliding retainers. In some implementations, a slidingretainer comprises a dovetail-shaped retaining cavity, for exampleconfigured to interact with a dovetail-shaped protrusion of anotherdevice.

The sliding retainers 6930A, 6930B are configured to receive a slotprotrusion of another device. For example, FIG. 69D schematically showsan example of another device 6950 interacting with the sliding retainer6930B. One or more devices may interact with one or both of the slidingretainers 6930A, 6930B (e.g., sliding in from one or either end of thesliding retainers 6930A, 6930B). The example device 6950 includes a slotprotrusion 6952 and a radially outwardly projecting part 6954. Theprojecting part 6954 may take any variety of shapes and sizes. Thedevice 6950 can be slid into the retaining cavity of the structure 6930Bafter the device 6900 has been positioned in a natural capsular bag ofan eye. Sliding the device 6950 anterior to posterior may be physicallyless difficult than, for example, sliding a device 6850 from a side,particularly in a later procedure. Coupling the device 6950 afterpositioning of the device 6900, for example as opposed to coupling orintegrally forming the device 6950 to the device 6900 before positioningthe device 6900 in an eye, can allow the device 6900 to be injectedthrough a smaller opening as described herein. Coupling the device 6950,for example as opposed to coupling or integrally forming the device 6950with the device 6900, can allow a variety of other devices 6950 to beused. In some implementations, the other device may be removed (e.g., bysliding out the side of the sliding retainer, by radially pulling out ifthe sliding retainer material is resilient, etc.) and a replacement orother device may optionally be coupled during a later procedure. In someimplementations, the other device may be absorbed over time, and areplacement or other device may optionally be coupled during a laterprocedure.

The sliding retainers 6930A, 6930B may be formed during formation of thedevice 6900 (e.g., as part of a molding process) and/or formed afterformation of the device 6900 (e.g., by a laser, chemical, or mechanicalremoval process). In some implementations, the housing structure 6912may comprise a different material than the sliding retainers 6930A,6930B (e.g., the housing structure 6912 comprising silicone and thesliding retainers 6930A, 6930B comprising polyimide). The slidingretainers 6930A, 6930B may be integral with or separate from the ringstructure portions 6920A, 6920B, 6920C, 6920D.

FIG. 70A illustrates an anterior side perspective view of an exampleprosthetic capsular device 7000. FIG. 70B illustrates an anterior planview of the example prosthetic capsular device 7000 of FIG. 70A. FIG.70C illustrates a side view of the example prosthetic capsular device7000 of FIG. 70A. The device 7000 comprises ring structure portions7020A, 7020B, 7020C, 7020D. The ring structure portions 7020A, 7020B,7020C, 7020D comprise openings 7028A, 7028B, 7028C, 7027D, respectively,which may provide one or more of the advantages discussed herein withrespect to openings of other ring structure portions. The device 7000further comprises interior openings or eyelets or grommets 7038A, 7038B,7038C, 7038D, 7038E, 7038F, 7038G, 7038H, 7038I, 7038J. The openings7038A, 7038B, 7038C, 7038D, 7038E, 7038F, 7038G, 7038H, 7038I, 7038J arein the capsule of the housing structure 7012 of the device 7000. Theopenings 7038A, 7038B, 7038C, 7038D, 7038E, 7038F, 7038G, 7038H, 7038I,7038J may be formed from the same material as (e.g., integral with) thering structure portions 7020A, 7020B, 7020C, 7020D. Other positions,quantities, and shapes of the openings are also possible. For example,the device 7000 may comprise only one interior opening, only twointerior openings, only three interior openings, only four interioropenings, only five interior openings, only six interior openings, onlyseven interior openings, only eight interior openings, only nineinterior openings, only ten interior openings, or more than ten interioropenings. The openings 7038A, 7038B, 7038C, 7038D, 7038E, 7038F, 7038G,7038H, 7038I, 7038J are illustrated as being extending inwardly fromends of the housing structure 7012, but the openings may extend inwardlyfrom sides of the housing structure 7012 and/or outwardly from thehousing structure 7012. The openings 7038A, 7038B, 7038C, 7038D, 7038E,7038F, 7038G, 7038H, 7038I, 7038J may be longitudinally aligned orparallel to the ring structure portions 7020A, 7020B, 7020C, 7020D,anterior to the ring structure portions 7020A, 7020B, 7020C, 7020D,and/or posterior to the ring structure portions 7020A, 7020B, 7020C,7020D. Each of the openings 7038A, 7038B, 7038C, 7038D, 7038E, 7038F,7038G, 7038H, 7038I, 7038J may be the same as the others of the openings7038A, 7038B, 7038C, 7038D, 7038E, 7038F, 7038G, 7038H, 7038I, 7038J. Atleast one of the openings 7038A, 7038B, 7038C, 7038D, 7038E, 7038F,7038G, 7038H, 7038I, 7038J may be different than at least one of theother openings 7038A, 7038B, 7038C, 7038D, 7038E, 7038F, 7038G, 7038H,7038I, 7038J. The openings 7038A, 7038B, 7038C, 7038D, 7038E, 7038F,7038G, 7038H, 7038I, 7038J may provide an anchor point, for exampleinteracting with a protrusion, for another device to be held inside thedevice 7000. Other devices can be coupled to one or more of the openings7038A, 7038B, 7038C, 7038D, 7038E, 7038F, 7038G, 7038H, 7038I, 7038Jafter the device 7000 has been positioned in a natural capsular bag ofan eye. Coupling the other device(s) after positioning of the device7000, for example as opposed to coupling or integrally forming the otherdevice(s) to the device 7000 before positioning the device 7000 in aneye, can allow the device 7000 to be injected through a smaller openingas described herein. Coupling other device(s), for example as opposed tocoupling or integrally forming the other device(s) with the device 7000,can allow a variety of other devices to be used. In someimplementations, the other device(s) may be removed and a replacement orother device may optionally be coupled during a later procedure. In someimplementations, the other device(s) may be absorbed over time, and areplacement or other device may optionally be coupled during a laterprocedure. The openings 7038A, 7038B, 7038C, 7038D, 7038E, 7038F, 7038G,7038H, 7038I, 7038J may be formed during formation of the device 7000(e.g., as part of a molding process) and/or formed after formation ofthe device 7000. In some implementations, the housing structure 7012 maycomprise a different material than the material surrounding the openings7038A, 7038B, 7038C, 7038D, 7038E, 7038F, 7038G, 7038H, 7038I, 7038J(e.g., the housing structure 7012 comprising silicone and the openingsurrounding material comprising polyimide).

FIG. 71A illustrates a perspective view of an example device 7140 forcoupling to a prosthetic capsular device. The device 7140 comprises afirst attachment portion 7142 and a second functional portion 7144. Thefirst attachment portion 7142 illustrated in FIG. 71A comprises ahairpin structure. The hairpin structure 7142 extends from the secondfunctional portion 7144 then turns back towards the second functionalportion 7144. As illustrated in FIG. 71A, the hairpin structure 7142turns approximately 270°, then reverses 180° three times to formundulations like a hairpin. The first turn may be larger than the laterturns. The hairpin structure 7142 may comprise fewer turns, including asingle turn that may be less than 270°. The second functional portion7144 may comprise a drug eluting device. For example, the secondfunctional portion 7144 may comprise a cage configured to holdmedicament pellets. The medicament may elute through sidewalls of thecage. The cage may comprise an opening 7146, for example allowing forthe insertion and/or removal of medicament pellets. In someimplementations, the second functional portion 7144 comprises adifferent type of medicament device, an electronic device, etc.

FIG. 71B illustrates an example coupling of the example device 7140 ofFIG. 71A with an example portion 7138 of a prosthetic capsular device.The portion 7138 may be similar, for example, to the openings 6728A1,6728B1, 6728C1, 6728D1, 6728A2, 6728B2, 6728C2, 6728D2, 6728A3, 6728B3,6728C3, 6728D3 of the device 6700, the openings 7038A, 7038B, 7038C,7038D, 7038E, 7038F, 7038G, 7038H, 7038I, 7038J, or other openings orattachment structures. The tail end of the hairpin structure 7142 isinserted through the opening 7138 and slid until the opening 7138 isproximate to the first turn, which can lock the device 7140 in position.In some implementations, a plurality of devices can be directly coupledto a single opening 7138. In some implementations, a plurality ofdevices can be coupled to a single opening 7138, for example a firstdevice 7140 anchoring to the opening 7138 and then at least one otherdevice anchoring to anchor structure 7142 (e.g., along differentlongitudinal positions of the anchor structure 7142).

FIG. 71C illustrates an example coupling of an example device 7150 withan example portion 7138 of a prosthetic capsular device. The device 7150comprises a first attachment portion 7152 and a second functionalportion (not shown) extending from the first attachment portion 7152.The first attachment portion 7152 comprises a carabiner structure 7152.The carabiner structure 7152 comprises a C-shaped frame 7153 and a gate7154. The gate 7154 is coupled to the frame 7153 at a hinge 7155. In anopen configuration in which the gate 7154 pivots inside the frame 7153,an opening or gap 7158 is formed between the end 7156 of the gate 7154and the end 7157 of the frame 7153, allowing the frame 7153 to bepositioned in an opening 7138. In a closed configuration in which thegate 7154 pivots outward, the gap 7158 is removed and the end 7156 ofthe gate 7154 and the end 7157 of the frame 7153 make contact,inhibiting or preventing the frame 7153 from sliding out of the opening7138. The frame 7153 may comprise shapes other than C-shaped. The gate7155 may comprise shapes other than substantially linear. In someimplementations, the ends 7156, 7157 are configured to enhanceinteraction in the closed position (e.g., comprising complementaryshapes). The second functional portion may comprise a drug elutingdevice, for example similar to the second functional portion 7144 ofFIGS. 71A and 71B. The portion 7138 may be similar, for example, to theopenings 6728A1, 6728B1, 6728C1, 6728D1, 6728A2, 6728B2, 6728C2, 6728D2,6728A3, 6728B3, 6728C3, 6728D3 of the device 6700, the openings 7038A,7038B, 7038C, 7038D, 7038E, 7038F, 7038G, 7038H, 7038I, 7038J, or otheropenings or attachment structures. In some implementations, a pluralityof devices can be directly coupled to a single opening 7138. In someimplementations, a plurality of devices can be coupled to a singleopening 7138, for example a first device 7150 anchoring to the opening7138 and then at least one other device anchoring to carabener structure7152.

FIG. 71D illustrates an example coupling of an example device 7160 withan example portion 7138 of a prosthetic capsular device. The device 7160comprises a first attachment portion 7162 and a second functionalportion 7166. The first attachment portion 7162 extends from the secondfunctional portion 7166 by a member 7165. The first attachment portion7162 comprises an arrowhead structure 7162. The arrowhead structure 7162comprises a point 7163 and barbs 7164 pointing away from the point 7163.The arrowhead structure 7162 may be at least partially deformable in afirst direction of the point 7163 and generally non-deformable in asecond direction away from the point 7163.

The second functional 7166 portion may comprise a drug eluting device,for example similar to the second functional portion 7144 of FIGS. 71Aand 71B. The portion 7138 may be similar, for example, to the openings6728A1, 6728B1, 6728C1, 6728D1, 6728A2, 6728B2, 6728C2, 6728D2, 6728A3,6728B3, 6728C3, 6728D3 of the device 6700, the openings 7038A, 7038B,7038C, 7038D, 7038E, 7038F, 7038G, 7038H, 7038I, 7038J, or otheropenings or attachment structures. The point 7163 is inserted throughthe opening 7138 until the barbs 1764 are on the opposite side of theopening 7138, which can lock the device 7160 in position.

Examples of drugs or medicaments that may be compatible with one or moreof the devices described herein are non-limiting. Further and morecreative solutions may be developed for the delivery of pharmaceutical,biologic, monoclonal antibodies, chemotherapeutic, radiation emittingand/or genetic (e.g., stem cell) therapies inside the eye. Certaindevices described herein are designed with the future in mind bypreserving and protecting an open space in the anterior segment of theeye (e.g., the internal volume of the device that outside the opticalpath) for the potential placement of controlled distribution devices fortreatment of pathologic, refractive, aesthetic, etc. conditions. Theease of access to this space through an anterior segment approach(cornea, limbus, or scleral tunnel) can advantageously allow placement,modification, exchange, replacement, and/or removal of such medicamentdelivery devices, providing long-term viability to implants that mayhave a finite duration of effectiveness.

Bimatoprost SR (Lumigan® from Allergan, Inc.) is an example of a timereleased drug that is effective (e.g., has been shown to successfullyreduce intraocular pressure for treatment of glaucoma and/or ocularhypertension), but non-reversible (e.g., not able to be removed from theeye and/or potentially requiring rescue therapy) and impractical toimplement. The drug pellet is placed into the anterior chamber of theeye through a small needle (e.g., intracameral injection) and left tofloat and drift inside the anterior segment without sequestration.Adverse outcomes could include loss of endothelial cells, cataractformation, iritis, and allergic reaction to one of the components in theimplant (drug and/or vehicle). Drugs having a cosmetic or aestheticeffect may also be used. For example, a higher dosage version ofbimatoprost is sold by Allergan as an eyelash growth serum, which may bedeveloped into an implant form. Other non-limiting examples ofmedicaments include a fluocinolone acetonide implant (Iluvien® fromAlimera Sciences, Inc. of Alpharetta, Ga.) and a dexamethasoneintravitreal implant (Ozurdex® from Allergan, Inc.). These examples areslowly dissolving steroid implants that are injected into the vitreouscavity, left to float in the vitreous with no control over migration.Traditionally, steroids have also been injected into the vitreous as abolus of the steroid suspension (such as triamcinolone), which can causea visual disturbance since the drug suspension can form a white opaquecloud covering vast portions of the visual field. Drugs implantsdesigned for long term delivery have also been developed with surgicallyimplanted carriers. For example, the ganciclovir intravitreal implant(Vitrasert® from Auritec Pharmaceuticals, Inc.) for treatment of CMVretinitis and the fluocinolone acetonide (Retisert® from Bausch & LombInc.) are both designed as slowly dissolvable drug inside a carrier thatmust be surgically implanted through the sclera directly into thevitreous, requiring suture fixation to the sclera. These are nottechnically easy to perform, even by a skilled ophthalmic surgeon, andcarry associated morbidity such as retinal detachment, infection, andblindness.

Neurotech Pharmaceuticals, Inc. of Cumberland, R.I. is developing animplant (NT-503) for its encapsulated cell therapy that is designed tobe sutured to the sclera. The Neurotech implant contains a live cellculture that has been modified to produce proteins that function as avascular endothelial growth factor (VEGF) trap. The cell culture is keptalive through nutrients available inside the eye, effectively acting asan implantable biologic drug producing factory.

FIG. 75A illustrates an anterior plan view of an example prostheticcapsular device system 7500. The system 7500 includes a prostheticcapsular device 7501 (e.g., having features of the device 5800, otherdevices described herein, etc.). For example, the device 7501 maycomprise openings to allow medicament to flow into the anterior chamberand/or the posterior chamber. The device 7501 includes an anchoringstructure 7502 configured to interact with a medicament delivery device.The anchoring structure 7502 includes a first pole or rod or bar or rail7502A and a first pole or rod or bar or rail 7502B. The system 7500 isillustrated in FIG. 75A as comprising one medicament delivery device7504 interacting with the second rail 7502B to better illustrate thefirst rail 7502A, but the system 7500 could include two medicamentdelivery devices 7504 (e.g., one on each lateral side of a posterioroptic 7510) or a plurality of medicament delivery devices (e.g., aplurality on one lateral side of the posterior optic 7510). The firstrail 7502A is anchored to the housing structure of the device 7501 andextends, as illustrated in FIG. 75A, to the left, with a free end on theleft side. The first rail 7502A may comprise a same material as and/orintegral with a ring structure portion. The first rail 7502A may be thesame as the rail 7502B (e.g., a mirror image (e.g., both anchored on theright), reversed (identical but the rail 7502B anchored on the left),etc.). The first rail 7502A may be different than the rail 7502B. Forexample, the first rail 7502A may have a different property (e.g.,length, cross-sectional area (e.g., diameter), lateral position, anchorpoint, shape, material, etc.) than the second rail 7502B. In someimplementations, the device 7501 comprises a plurality of rails on oneside of the optic 7510. For example, the device 7501 may comprise afirst rail extending laterally from left to right and a second railextending laterally from right to left. The device 7501 may also oralternatively comprise one or more rails on the left and/or right sidesof the optic 7510. The device 7501 may be deployed in a capsulorhexis.In some implementations, the system 7500 may be used as a medicamentdelivery system without containing an IOL.

FIG. 75B illustrates an anterior plan view of an example medicamentdelivery device 7504 of the prosthetic capsular device system 7500 ofFIG. 75A. The medicament delivery device 7504 comprises a shell or cage7508 containing or configured to contain a medicament. In someimplementations, the cage 7508 comprises a mesh structure configured tointeract with fluid (e.g., anterior chamber fluid) in the device 7501.In some implementations, the medicament may comprise a bacterial cultureconfigured to provide a protein as a waste product. In certain suchimplementations, the bacteria may derive nutrients from the anteriorchamber fluid. In some implementations, the cage 7508 comprises aselective membrane (e.g., an osmotic membrane) configured to allowmedicament to flow out to the device 7501. The details of the cage 7508may vary based on the medicament. The medicament delivery device 7504maybe inserted into the device 7501 before and/or after an IOL. Themedicament delivery device 7504 may be folded for insertion into thedevice 7501, then unfold (e.g., self-expand, be unfolded) in the capsuleof the device 7501. The medicament delivery device 7504 includes aplurality of tubes or ducts or pipes or sleeves 7506A, 7506B, 7506Cconfigured to interact with the second rail 7502B. The free end of therail 7502B, on the right side in FIG. 75A, can be inserted into an openend of the first sleeve 7506A, through the first sleeve 7506A, into anopen end of the second sleeve 7506B, through the second sleeve 7506B,into an open end of the third sleeve 7506C, and through the third sleeve7506C, for example by rotating the medicament delivery device 7504clockwise. The rail 7502B inhibits or prevents the medicament deliverydevice 7504 from migrating in the device 7501, for example because thesleeves 7506A, 7506B, 7506C, which are coupled to the device body 7508,are inhibited from moving. More or fewer sleeves are also possible. Insome implementations, features other than sleeves can be configured tointeract with a rail.

The cage 7508 may include an opening or slit configured to allowinsertion of medicament after insertion into the device 7501. Forexample, the cage 7508 may be inserted empty, and then a drug may beinserted through the opening or slit, thereafter inhibited or preventedfrom migrating out of the medicament delivery device 7504. In someimplementations, the cage 7508 may be inserted with a first drug implantinside, and once that drug loses effectiveness, a second drug implant,which may be the same or different than the first drug implant, may beinserted. In some implementations, the medicament delivery device 7504may be removed (e.g., by rotating counter-clockwise to disengage therail 7502B from the sleeves 7506A, 7506B, 7506C) and a second medicamentdelivery device 7504 may be inserted in the device 7501. In someimplementations, a second medicament delivery device 7504 may beinserted in the device 7501 while the first medicament delivery device7504 remains (e.g., interacting with the rail 7502A or also interactingwith the rail 7502B). For example, the full benefit of the medicament inthe first medicament delivery device 7504 may be realized (e.g.,exhausting all of the active ingredient(s)) without a reduction ineffectiveness over time due to decreasing dosage.

FIG. 75C illustrates an anterior plan view of another example medicamentdelivery device 7514 of a prosthetic capsular device system. The device7514 comprises a cage 7508 and a pole or rod or bar or rail 7516. Therail 7516 may be configured to interact with one or a plurality of tubesor ducts or pipes or sleeves of a prosthetic capsular device (e.g., aninverse of the system 7500). In some implementations, a first side of aprosthetic capsular device comprises a rail and a second side of theprosthetic capsular device comprises a plurality of sleeves.

FIG. 75D illustrates an anterior side perspective view of anotherexample medicament delivery device 7550 of a prosthetic capsular devicesystem. The device 7550 includes a framework 7552, a first cage 7554A,and a second cage 7554B. The framework 7552 may comprise a ring (e.g.,as illustrated in FIG. 75D), a plurality of rings (e.g., an upper ring,a lower ring, an intermediate ring, a partial ring in the area of thecage 7554B), struts between rings, broken rings (e.g., to aidflexibility for insertion), combinations thereof, and the like. Theframework 7552 may comprise a flexible material capable of or configuredto revert to an original shape once inserted into the cavity of aprosthetic capsular device. For example, the framework 7552 may comprisepolyimide, polyamide, PLLA, PLGA, superelastic alloys (e.g., nitinol,chromium-cobalt), etc. The cages 7554A, 7554B may be, for example,similar to the cage 7508. The device 7550 may comprise only one cage,two cages, or more than two cages. One or both of the cages 7554A, 7554Bmay be coupled to the framework 7552, for example, by threading a railof the framework 7552 through sleeves (e.g., as described with respectto FIGS. 75A and 75B). One or both of the cages may be coupled to theframework 7552, for example, by adhesive, welding, chemical adhesion,intertwining, combinations thereof, and the like. The device 7550 iscapable of or configured to be inserted into a prosthetic capsulardevice that does not necessarily include any features configured tointeract with the device 7550. The framework may self-expand within acavity of the prosthetic capsular device radially outward of an anterioropening, anchoring the device 7550 in place. The device 7550 can beremoved from the prosthetic capsular device, for example aftermedicament in the cages 7554A, 7554B has been exhausted. A second device7550 may be inserted after removal of the first device 7550. In someimplementations, multiple devices 7550 (e.g., having a smallerthickness, different shapes of devices 7550 that may be configured tofit together, etc.) may be inserted into a prosthetic capsular device.

FIG. 75E illustrates an anterior side perspective view of an exampleprosthetic capsular device system 7560 including the medicament deliverydevice 7550 of FIG. 75D. The device 7550 has been inserted into theprosthetic capsular device. The cages 7554A, 7554B are out of the visualaxis, for example at least partially defined by a portion of or theentire posterior refractive surface. The prosthetic capsular device neednot have any special features configured to engage the device 7550 apartfrom a cavity. In some implementations, the prosthetic capsular devicemay include a lip, posts, or the like configured to interact with thedevice 7550. In some implementations, the shape of the framework 7552may correspond or substantially correspond to a lateral cross-sectionalshape or a volume of the cavity of the prosthetic capsular device, forexample to increase or maximize the internal volume available for thecages 7554A, 7554B.

FIG. 76A illustrates an anterior plan view of an example prostheticcapsular device 7600. To aid understanding, the device 7600 is shownholding an IOL 7602 (e.g., Akreos® Adapt AO from Bausch and Lomb). TheIOL 7602 comprises a plurality of openings or holes or apertures 7604A,7604B, 7604C, 7604D. The device 7600 comprises a plurality of poles orcolumns or pillars or posts 7606A, 7606B, 7606C, 7606D. The posts 7606A,7606B, 7606C, 7606D are configured to interact with the apertures 7604A,7604B, 7604C, 7604D. The interaction may inhibit or prevent rotation ofthe IOL 7602 within the device 7600, for example because the posts7606A, 7606B, 7606C, 7606D bear against the insides of the apertures7604A, 7604B, 7604C, 7604D. The device 7600 may comprise more or fewerposts 7606A, 7606B, 7606C, 7606D. For example, the posts 7606B, 7606D,the posts 7606A, 7606C, or other combinations may be omitted. Foranother example, additional posts may be added, for example inward ofthe rounded recesses formed between the outward protrusions and theoptic of the IOL 7602. Although illustrated as generally cylindrical,the posts 7606A, 7606B, 7606C, 7606D may take other shapes (e.g.,oblong, polygonal, configured to match the shapes of the apertures7604A, 7604B, 7604C, 7604D, etc.).

FIG. 76B illustrates an anterior plan view of an example prostheticcapsular device 7610. To aid understanding, the device 7610 is shownholding an IOL 7612 (e.g., enVista™ from Bausch and Lomb). The IOL 7612comprises a plurality of openings or holes or apertures 7614A, 7614B.The device 7610 comprises a plurality of poles or columns or pillars orposts 7616A, 7616B. The posts 7616A, 7616B are configured to interactwith the apertures 7614A, 7614B. The interaction may inhibit or preventrotation of the IOL 7612 within the device 7610, for example because theposts 7616A, 7616B bear against the insides of the apertures 7614A,7614B. The device 7610 may comprise more or fewer posts 7616A, 7616B.For example, the post 7616A or the post 7616B may be omitted. Foranother example, additional posts may be added, for example inward ofthe haptics of the IOL 7612. Although illustrated as generallycylindrical, the posts 7616A, 7616B may take other shapes (e.g., oblong,polygonal, configured to match the shapes of the apertures 7614A, 7614B,etc.).

FIG. 76C illustrates an anterior plan view of an example prostheticcapsular device 7620. FIG. 76D illustrates an anterior plan view of anexample prosthetic capsular device 7630. To aid understanding, thedevices 7620, 7630 are each shown holding an IOL 7622 (e.g., Akreos®MICS from Bausch and Lomb). The IOL 7622 comprises a plurality ofopenings or holes or apertures 7624A, 7624B, 7624C, 7624D. The device7620 comprises a plurality of poles or columns or pillars or posts7626A, 7626B, 7626C, 7626D at the radially outward edges of the haptics.The posts 7626A, 7626B, 7626C, 7626D are configured to interact with theapertures 7624A, 7624B, 7624C, 7624D. The interaction may inhibit orprevent rotation of the IOL 7622 within the device 7620, for examplebecause the posts 7626A, 7626B, 7626C, 7626D bear against the insides ofthe apertures 7624A, 7624B, 7624C, 7624D. The device 7620 may comprisemore or fewer posts 7626A, 7626B, 7626C, 7626D. For example, the posts7626B, 7626D, the posts 7626A, 7626C, or other combinations may beomitted. For another example, additional posts may be added, for exampleconfigured to interact with the apices between the haptics of the IOL7622. Although illustrated as generally cylindrical in FIG. 76C, theposts 7626A, 7626B, 7626C, 7626D may take other shapes (e.g., oblong,polygonal, configured to match the shapes of the apertures 7624A, 7624B,7624C, 7624D (e.g., as the posts 7636A, 7636B, 7636C, 7636D of thedevice 7630), etc.).

FIG. 76E illustrates an anterior plan view of an example prostheticcapsular device 7640. To aid understanding, the device 7640 is shownholding an IOL 7642 (e.g., Tecnis® Toric from Abbott Medical Optics).The IOL 7642 comprises a plurality of rounded recesses 7644A, 7644B. Thedevice 7640 comprises a plurality of poles or columns or pillars orposts 7646A, 7646B. The posts 7646A, 7646B are configured to interactwith the apertures 7644A, 7644B. In some implementations, the roundedrecesses 7644A, 7644B can snap around the posts 7646A, 7646B. Theinteraction may inhibit or prevent rotation of the IOL 7642 within thedevice 7640, for example because the posts 7646A, 7646B bear against theinsides of the recesses 7644A, 7644B. The device 7640 may comprise moreor fewer posts 7646A, 7646B. For example, the post 7646A or the post7646B may be omitted. For another example, additional posts may beadded. Although illustrated as generally cylindrical, the posts 7646A,7646B may take other shapes (e.g., oblong, polygonal, configured tomatch the shapes of the apertures 7644A, 7644B, etc.).

FIG. 76F illustrates an anterior plan view of an example prostheticcapsular device 7650. To aid understanding, the device 7650 is shownholding an IOL 7652 (e.g., AcrySof® IQ Toric from Alcon). The IOL 7652does not comprise openings or recesses of note. The device 7650comprises a plurality of poles or columns or pillars or posts 7656A,7656B, 7656C, 7656D. The posts 7656A, 7656B, 7656C, 7656D are configuredto interact with the haptics of the IOL 7652. The interaction mayinhibit or prevent rotation of the IOL 7652 within the device 7650, forexample because the posts 7656A, 7656B, 7656C, 7656D bear against thesides of the haptics. The device 7650 may comprise more or fewer posts7656A, 7656B, 7656C, 7656D. For example, the posts 7656A, 7656B, theposts 7656C, 7656D, or other combinations may be omitted. For anotherexample, additional posts may be added, for example configured to actwith other portions of the haptics and/or the optic portion of the IOL7652. Although illustrated as generally cylindrical, the posts 7656A,7656B, 7656C, 7656D may take other shapes (e.g., oblong, polygonal,configured to match the shapes of haptic features, etc.).

Several examples of prosthetic capsular device features configured tointeract with example IOL features are explicitly provided herein, otherhousing shapes, posts, openings, insulated areas, combinations thereof,etc. may be adapted for other IOLs or other devices that may becontained in the device.

FIG. 72A illustrates an anterior side perspective view of an exampleprosthetic capsular device 7200. The device 7200 comprises interiorstructures or hairpins 7238A, 7238B, 7238C, 7238D. The hairpins 7238A,7238B, 7238C, 7238D are in the capsule of the housing structure 7212 ofthe device 7200. FIG. 72B illustrates a magnified side view of anexample portion 7038, representative of one of the hairpins 7238A,7238B, 7238C, 7238D, of the example prosthetic capsular 7200 device ofFIG. 72B. The hairpin 7238 comprises an anchor portion 7240, for exampleconfigured to anchor the hairpin 7238 in the housing structure 7212. Thehairpin 7238 further comprises a pin portion 7042 extending radiallyinward from the anchor portion 7240 and then turning to extend radiallyoutward. As illustrated in FIG. 72B, the hairpin 7038 turnsapproximately 270°, then reverses 180° three times to form undulationslike a hairpin. The first turn may be larger than the later turns. Thehairpin 7238 may comprise fewer turns, including a single turn that maybe less than 270°. FIG. 72B shows interaction of the hairpin 7238 with aloop structure 7252 of another device 7250 (which could include acontainer formed out of any biocompatible material including but notlimited to surgical suture material such as silk, prolene, gortex,nylon, vicryl, or the like). The loop structure 7252 can be positionedproximate to the radially inward extension of the hairpin 7238 and slidradially inward to be proximate to the first turn, which can lock thedevice 7250 into position. In some implementations, a plurality of otherdevices can be coupled to a single hairpin 7238, for example allanchoring proximate to the first turn or anchoring along differentlongitudinal positions of the radially inward extension. The hairpin7238 may be compatible with other types of attachment structures, forexample the hairpin structure 7142 of FIGS. 71A and 71B, the carabiner7150 of FIG. 71C, the arrowhead structure 7162 of FIG. 71D, etc.

The hairpins 7238A, 7238B, 7238C, 7238D may be formed from the samematerial as (e.g., integral with) the ring structure portions 7220A,7220B, 7220C, 7220D. Other positions, quantities, and shapes of theopenings are also possible. For example, the device 7200 may compriseonly one hairpin, only two hairpins, only three hairpins, only fourhairpins, or more than four hairpins. The hairpins 7238A, 7238B, 7238C,7238D are illustrated as being extending inwardly from ends of thehousing structure 7212, but the hairpins may extend inwardly from sidesof the housing structure 7212 (e.g., like the hairpins 7238E, 7238F ofFIG. 72A) and/or outwardly from the housing structure 7212. Each of thehairpins 7238A, 7238B, 7238C, 7238D may be the same as the others of thehairpins 7238A, 7238B, 7238C, 7238D. At least one of the hairpins 7238A,7238B, 7238C, 7238D may be different than at least one of the otherhairpins 7238A, 7238B, 7238C, 7238D. The hairpins 7238A, 7238B, 7238C,7238D may provide an anchor point, for example interacting with aprotrusion, for another device to be held inside the device 7200. Otherdevices can be coupled to one or more of the hairpins 7238A, 7238B,7238C, 7238D after the device 7200 has been positioned in a naturalcapsular bag of an eye. Coupling the other device(s) after positioningof the device 7200, for example as opposed to coupling or integrallyforming the other device(s) to the device 7200 before positioning thedevice 7200 in an eye, can allow the device 7200 to be injected througha smaller opening as described herein. Coupling other device(s), forexample as opposed to coupling or integrally forming the other device(s)with the device 7200, can allow a variety of other devices to be used.In some implementations, the other device(s) may be removed and areplacement or other device may optionally be coupled during a laterprocedure. In some implementations, the other device(s) may be absorbedover time, and a replacement or other device may optionally be coupledduring a later procedure. The hairpins 7238A, 7238B, 7238C, 7238D may beformed during formation of the device 7200 (e.g., as part of a moldingprocess) and/or formed after formation of the device 7200. In someimplementations, the housing structure 7212 may comprise a differentmaterial than the material surrounding the hairpins 7238A, 7238B, 7238C,7238D (e.g., the housing structure 7212 comprising silicone and thehairpins 7238A, 7238B, 7238C, 7238D comprising polyimide).

As seen in FIG. 58A, but perhaps best seen in FIGS. 58C and 58D, thering structure 5820 extends from the housing structure 5812 at aposition anterior to a longitudinal midline of the device 5800, whichmay create separation between the anterior capsule and posteriorcapsule, which could play a role in use of the device 5800 to provideaccommodation.

FIG. 59A illustrates a side view of an example prosthetic capsulardevice 5900. The device 5900 can provide accommodation, as explained infurther detail below. The device 5900 comprises a housing structure5912, a ring structure 5920, and a refractive surface 5910. The ringstructure 5920 may be similar, for example, to the ring structure 5820.In some implementations, the ring structure 5920 can allow the device5900 to be sutured to parts of an eye such as a natural capsular bag,zonules, ciliary muscles, etc. The refractive surface 5910 may besimilar, for example, to the refractive surface 5810. The housingstructure 5912 may be similar to, for example, the housing structure5812. The end portions of the housing structure 5912 may arch posteriorto the central plane of the central plane of the refractive surface5910, placing the refractive surface 5910 in a relatively anteriorposition (e.g., compared to the refractive surface 5810), in the absenceof outside forces (e.g., capsular forces). The housing structure canhave an arch amount 5930 that may be measured by angle, distance, and/orpercentage. In some implementations, the arch amount 5930 is betweenabout 10° and about 50° (e.g., about 10°, about 20°, about 25°, about30°, about 35°, about 40°, about 50°, ranges between such values, etc.).

The device 5900 comprises an opening 5908 spaced from the refractivesurface 5910. Different longitudinal or anterior-posterior positions ofthe refractive surface 5910, which may be at least partially measured bydistance from the relatively stable positioning of the opening 5908,provide different effective lens powers.

FIGS. 59B and 59C illustrate an example method of use of the exampleprosthetic capsular device 5900 of FIG. 59A. The device 5900 has beenpositioned in a natural capsular bag after a phacoemulsification. Thenatural capsular bag is surrounded by zonules 5942, which are connectedto ciliary muscles 5940. In a natural eye, the ciliary muscles 5940contract radially inward to focus on close objects (accommodation oraccommodated state), which allows the zonules 5942 to relax, allowingthe lens to relax and expand longitudinally; the ciliary muscles 5940relax radially outward when not focused on close objects(disaccomodation or dis-accomodated state), which tightens the zonules5942, longitudinally compressing the natural lens. The changes in lensshape alter the lens power, which provides focus abilities.

In FIG. 59B, the ciliary muscles 5940 are in a contracted state with thezonules 5942 relaxed for accommodation. Without forces from tightenedzonules 5942, the device 5900 can be in substantially the shape shown inFIG. 59A. The refractive surface 5910 is spaced from the opening 5808 bya distance 5946, which provides a first effective lens power. In FIG.59C, the ciliary muscles 5940 are in a relaxed or resting state with thezonules 5942 tightened for dis-accommodation. The outward forces fromthe tightened zonules 5942, as indicated by the arrow 5948, causes thedevice 5900 to stretch radially outwardly, resulting in a reduction inarch of the housing structure 5912. Reducing the arch of the housingstructure 5912 moves the refractive surface 5910 posterior, as indicatedby the arrow 5952. The position of the refractive surface 5910 is spacedfrom the opening 5908 by a distance 5954, which provides a secondeffective lens power less than the first effective lens power. If asubject focuses on a close object, the ciliary muscles 5940 willcontract, allowing the zonules 5942 to relax, as indicated by the arrow5950, and the refractive surface 5910 to move anterior, as indicated bythe arrow 5944, thereby increasing effective lens power. The effectivelens power of the device 5900 is thereby adjustable during naturalaccommodation. Rather than changing lens shape and actual lens power asin a natural lens, the same anatomy acts to change the position of therefractive surface 5910 and the effective lens power of the device 5900.

FIGS. 60A-60N illustrate an example method of loading and ejecting theexample prosthetic capsular device 5880 of FIG. 58E. FIG. 60A shows thedevice 5880 in a case 6002, for example similar to the case 5702. Thecase 6002 includes a first part 6010 and a second part 6011. The firstpart 6010 is spaced from the second part 6011 by a gap 6012. Each of thefirst part 6010 and the second part 6011 comprises a plurality offrustoconical posts 6014. The device 5880 is radially inward of theposts 6014. In FIGS. 60B and 60C, forceps 6004 (e.g., Cumming CrystaLensForceps from Miltex, Inc. of Plainsboro, N.J.) are used to remove thedevice 5880 from the case 6002. The gap 6012 allows one arm of theforceps 6004 to reach under the device 5880. In FIGS. 60D-60F, thedevice 5880 is loaded into an injector 6006 (e.g., Accuject 2.6 BL (backload) from Medicel AG of Wolfhalden, Switzerland). The forceps 6004continue to hold the device 5880 while the device 5880 is loaded into acavity of the injector 6006. The injector 6008 includes a snap lockmechanism 6008 to secure the device 5880 after loading. In FIGS. 60D and60E, the mechanism 6008 is open. In FIG. 60F, the mechanism 6008 issnapped closed. FIG. 60D also shows the distal tip 6016 of the injector6006.

FIGS. 60G-60M show the device 5880 being ejected from the distal tip6016 of the injector 6006 by longitudinal advancement of a plunger 6018,as indicated by the arrow 6019. The device 5880 stretches longitudinallyas the device 5880 is advanced through the injector 6006, which taperstowards the distal tip 6016. In FIG. 60G, the distance 6020 between thering portions of the device 5880 is indicative of a first level ofstretching. In FIG. 60H, the distance 6022 between the ring portions ofthe device 5880 is indicative of a second level of stretching. Thedistance 6022 is longer than the distance 6020 (as drawn, about 73%longer). In FIG. 60I, just before the device 5880 is about to start toexit the distal tip 6016 of the injector 6006, the distance 6024 betweenthe ring portions of the device 5880 is indicative of a third level ofstretching. The distance 6024 is longer than the distance 6020 (asdrawn, about 287% longer) and the distance 6022 (as drawn, about 65%longer). The stretching of the device 5880 is exponential as the device5880 advances through the taper of the injector 6006. Different amountsof stretching may be achieved by use of different materials, differentinjectors, etc.

In FIG. 60J, the device 5880 is starting to exit the distal tip 6016 ofthe injector 6006. The device 5880 begins to self-expand to resume apre-folded shape (see FIG. 60A) upon release from the injector 6006. Thesequence from FIGS. 60J to 60M can take less than one second, and theself-expansion or elastic spring back shown from FIG. 60L to FIG. 60M isfast enough to be almost imperceptible.

In FIG. 60N, the injector 6006 has been retracted. If the device 5880was in a natural capsular bag of an eye, a user may engage the openingsof the ring portions with a standard IOL positioning tool such as aLester IOL manipulator, for example to align the fins along a specificrotational axis.

Referring again to FIGS. 4B-4G and the description of example animalstudy procedures, FIGS. 44A-54E are photographs of results of an animalstudy conducted along the same lines. In five rabbits, a prostheticcapsular device 400 as shown in FIGS. 4G-4I and described above, andthen an IOL (AcrySof SN60AT, a single-piece hydrophobic acrylic IOLmanufactured by Alcon) were inserted into the right eye of each rabbit,and only an IOL was inserted into the left eye of each rabbit. Theprocedure for the prosthetic capsular device and IOL eyes was asdescribed above, and the procedure for the IOL-only eyes wassubstantially the same without the prosthetic capsular device steps.

FIGS. 44A and 44B are photographs of animal study results annotated tohighlight certain features. Since the location, shading, coloration,etc. can vary based on variations in device location, lighting, anatomy,and the like, FIGS. 44A and 44B are somewhat redundantly provided toprovide the reader with the ability to identify the identified featuresin the variety of photographs described herein. In FIGS. 45A-54C, fourphotographs are provided for each figure with different lightingconditions, focal points, angles, etc. to provide at least one figureillustrative of the condition of the eye; however, the photographs ineach figure are of the same eye at the same time (e.g., after one week,after two weeks, after three weeks, or after four weeks).

FIG. 44A, which is an annotated version of FIG. 49B (upper leftphotograph), illustrates an anterior capsulorhexis 4402 (shown by shortdashes), a refractive surface 4404 (shown by long dashes) of an IOL, ananterior opening 4406 (shown by intermediate dashes) of a prostheticcapsular device containing the IOL, and IOL haptics 4408. FIG. 44B,which is an annotated version of FIG. 49A (upper right photograph),illustrates an anterior capsulorhexis 4412 (shown by short dashes), arefractive surface 4414 (shown by long dashes) of an IOL, an anterioropening 4416 (shown by intermediate dashes) of a prosthetic capsulardevice containing the IOL, and IOL haptics 4418. Photographs of eyesused for control (e.g., consisting essentially of an IOL) do not show ananterior opening of a prosthetic capsular device.

Rabbit eyes are highly inflammatory such that each week in a rabbit isapproximately six months in a human. Four weeks in a rabbit, the lasttwo sets of photographs in each figure set (e.g., “D” and “E”), issubstantially equivalent to the effects after approximately two years ina human.

FIGS. 45A-45E are photographs of animal study results for a right eye ofa first rabbit. FIG. 45A is after one week, FIG. 45B is after two weeks,FIG. 45C is after three weeks, and FIGS. 45D and 45E are after fourweeks. FIGS. 45A-45E illustrate an anterior capsulorhexis 4502, arefractive surface 4504 of an IOL, an anterior opening 4506 of aprosthetic capsular device containing the IOL, and IOL haptics 4508. TheIOL haptics 4508 are not visible in some figures, although the positionof the haptics may be assumed based on other figures and/or the positionof any visible portions of the IOL flared radially outwardly to form thestart of the haptics.

As described above, the natural capsular bag undergoes chronic changesafter cataract surgery believed to be largely due to the presence andcontinued growth of epithelial cells remaining on the natural capsularbag. If the entire natural capsular bag becomes fibrotic, and phimosispersists, there can be zonular dehiscence and changes to the effectivelens position over time. Significant opacification of the naturalcapsular bag may be remedied by a Nd:YAG laser posterior capsulotomy.FIGS. 45A-45C show that epithelial cell migration and propagation hasbeen successfully mediated by use of the prosthetic capsular device.Even after four weeks, the natural capsular bag is substantially free ofPCO, which is best seen by comparison to FIGS. 46A-46D, which show theleft eye of the same rabbit during the same time periods. Without beingbound by any particular theory, the Applicant believes that theprosthetic capsular device filling or substantially filling the naturalspace or volume of the natural capsular bag inhibits or prevents PCO.

FIG. 45B shows a small tear 4510 in the prosthetic capsular device atapproximately a 9 o'clock position. Even with this small defect, whichwas not present in the other four eyes containing a prosthetic capsulardevice and which is not believed to be a chronic problem, no irritationor opacification is evidenced in eyes containing a prosthetic capsulardevice. The eyes containing a prosthetic capsular device show someirritation of the vitreous.

FIG. 45E shows a Soemmering's ring 4512 and material 4514 on a posteriorsurface of the IOL. The Soemmering's ring 4512 is a toroidal collectionof lens epithelial cells that have transformed and grown after thecataract has been removed. This occurs in the natural capsular bag afterremoval of the natural lens as a result of mesenchymal epithelialtransformation thought to be caused by a combination of inflammatorymediators and contact between the anterior capsule and the posteriorcapsule.

FIGS. 46A-46E are photographs of animal study results for a left eye ofthe first rabbit. FIG. 46A is after one week, FIG. 46B is after twoweeks, FIG. 46C is after three weeks, and FIGS. 46D and 46E are afterfour weeks. FIGS. 46A-46E illustrate an anterior capsulorhexis 4602, arefractive surface 4604 of an IOL, and IOL haptics 4608. The IOL haptics4608 are not visible in some figures, although the position of thehaptics may be assumed based on other figures and/or the position of anyvisible portions of the IOL flared radially outwardly to form the startof the haptics.

The first easily identifiable difference between the right eye of FIGS.45A-45D and the left eye of FIGS. 46A-46D is the significant fibrosis4612 of the natural capsular bag, even after only two weeks (FIG. 46B).Fibrosis, the epithelial-mesenchymal transition of the lens epithelialcells to muscle cells (or contractile tissue or myofibroblast tissue),can cause opacification and/or can increase the elasticity of thenatural capsular bag, which can cause contraction. Each are undesirable,but in combination, contraction and opacification can reduce an amountof light that can pass through the eye to the retina, reducing vision.

A normal eye under normal lighting conditions takes in light betweenabout 3 mm and about 6 mm. Under bright light conditions, the normal eyemay reduce light intake to between about 1 mm and about 2 mm. Under lowlight conditions, the normal eye may increase light intake to betweenabout 7 mm and about 8 mm. Due to the contraction and fibrosis, theeffective diameter at which the left eye of FIGS. 46A-46D can take inlight is about 4.1 mm, which significantly impairs the vision in thateye except under the best lighting conditions. The effective diametersprovided herein are rough approximations based on the photographs, butare precise enough to show visual impairment.

The second easily identifiable difference between the right eye of FIGS.45A-45D and the left eye of FIGS. 46A-46D is the migration or shiftingof the position of the IOL. The last figure (“E”) for each set of eyefigures, which is a gross section, best shows the centering of the IOL.The IOLs in the right eyes, which also include a prosthetic capsulardevice, were generally more centered and sat more posterior than theIOLs in the left eyes, in which the IOL is more flat in line with thecollapsed natural capsular bag.

FIG. 46E shows a Soemmering's ring 4614 and the inception of PCO 4616.As described in further detail herein, PCO is the formation of apartially opaque membrane by the reproduction of lens epithelial cellsalong the posterior of the natural capsular bag. In contrast, materialon the posterior surface, for example as described with respect to FIG.45E, is most likely retrained viscoelastic that has some residualtrapped fibrin or inflammatory precipitate contained within it.

FIGS. 47A-47E are photographs of animal study results for a right eye ofa second rabbit. FIG. 47A is after one week, FIG. 47B is after twoweeks, FIG. 47C is after three weeks, and FIGS. 47D and 47E are afterfour weeks. FIGS. 47A-47E illustrate an anterior capsulorhexis 4702, arefractive surface 4704 of an IOL, an anterior opening 4706 of aprosthetic capsular device containing the IOL, and IOL haptics 4708. TheIOL haptics 4708 are not visible in some figures, although the positionof the haptics may be assumed based on other figures and/or the positionof any visible portions of the IOL flared radially outwardly to form thestart of the haptics. The IOL is well centered in the prostheticcapsular device, which can be seen by the positions of the refractivesurface 4704 of the IOL and the anterior opening 4706 of the prostheticcapsular device. In contrast to FIGS. 45A-45D, FIGS. 47A-47D, as well asFIGS. 49A-49D, 51A-51D, and 53A-53D, show that the prosthetic capsulardevice was not torn, which is generally preferably even though tearingdid not cause irritation in the eye of the first rabbit. The naturalcapsular bag is substantially free of fibrosis.

FIG. 47E shows a Soemmering's ring 4712, material 4714 on the posteriorsurface of the IOL, material 4716 attached to the posterior capsule atthe vitreous face, and the inception of peripheral PCO 4718. FIG. 47Ealso shows a mild reaction in the anterior vitreous with some smallclumps of lymphocytes 4720 in the anterior vitreous, indicative of alow-grade vitritis.

FIGS. 48A-48E are photographs of animal study results for a left eye ofthe second rabbit. FIG. 48A is after one week, FIG. 48B is after twoweeks, FIG. 48C is after three weeks, and FIGS. 48D and 48E are afterfour weeks. FIGS. 48A-48E illustrate an anterior capsulorhexis 4802, arefractive surface 4804 of an IOL, and IOL haptics 4808. The IOL haptics4808 are not visible in some figures, although the position of thehaptics may be assumed based on other figures and/or the position of anyvisible portions of the IOL flared radially outwardly to form the startof the haptics. As in FIGS. 46A-46E, and in stark contrast to the righteye of FIGS. 47A-47E, the left eye of FIGS. 48A-48E evidence significantfibrosis 4812 of the natural capsular bag, best seen in FIG. 48C. FIGS.46A-46E also shown contraction of the anterior capsulorhexis 4802. Dueto the contraction and fibrosis, the effective diameter at which theleft eye of FIGS. 48A-48E can take in light is about 4.3 mm, whichsignificantly impairs the vision in that eye except under the bestlighting conditions.

FIGS. 49A-49E are photographs of animal study results for a right eye ofa third rabbit. FIG. 49A is after one week, FIG. 49B is after two weeks,FIG. 49C is after three weeks, and FIGS. 49D and 49E are after fourweeks. FIGS. 49A-49E illustrate an anterior capsulorhexis 4902, arefractive surface 4904 of an IOL, an anterior opening 4906 of aprosthetic capsular device containing the IOL, and IOL haptics 4908. TheIOL haptics 4908 are not visible in some figures, although the positionof the haptics may be assumed based on other figures and/or the positionof any visible portions of the IOL flared radially outwardly to form thestart of the haptics. The natural capsular bag is substantially free offibrosis. FIG. 49E shows material 4912 on a posterior surface of the IOLand the inception of peripheral PCO 4614.

FIGS. 50A-50E are photographs of animal study results for a left eye ofthe third rabbit. FIG. 50A is after one week, FIG. 50B is after twoweeks, FIG. 50C is after three weeks, and FIGS. 50D and 50E are afterfour weeks. FIGS. 50A-50E illustrate an anterior capsulorhexis 5002, arefractive surface 5004 of an IOL, and IOL haptics 5008. The IOL haptics5008 are not visible in some figures, although the position of thehaptics may be assumed based on other figures and/or the position of anyvisible portions of the IOL flared radially outwardly to form the startof the haptics. Out of all the left eyes, FIGS. 50A-50E show the mostdramatic contraction of the natural capsular bag, which can be seen bythe size of the anterior capsulorhexis 4902. Due to the contraction andfibrosis, the effective diameter at which the left eye of FIGS. 50A-50Ecan take in light is about 4.2 mm, which significantly impairs thevision in that eye except under the best lighting conditions. FIG. 50Ealso shows PCO.

FIGS. 51A-51E are photographs of animal study results for a right eye ofa fourth rabbit. FIG. 51A is after one week, FIG. 51B is after twoweeks, FIG. 51C is after three weeks, and FIGS. 51D and 51E are afterfour weeks. FIGS. 51A-51E illustrate an anterior capsulorhexis 5102, arefractive surface 5104 of an IOL, an anterior opening 5106 of aprosthetic capsular device containing the IOL, and IOL haptics 5108. TheIOL haptics 5108 are not visible in some figures, although the positionof the haptics may be assumed based on other figures and/or the positionof any visible portions of the IOL flared radially outwardly to form thestart of the haptics. FIGS. 51A-51E show that the prosthetic capsulardevice may have been poorly centered in the natural capsular bag and/orthat the natural capsular bag contracted, but the natural capsular bagis substantially free of fibrosis such that mis-centering and/orcontraction does not present a serious issue, as light may pass throughthe still-epithelial natural capsular bag cells. FIG. 51E shows material5112 on a posterior surface of the IOL. The right eye of the fourthrabbit also shows a small amount of fibrin peripherally between theprosthetic capsular device and the IOL, discussed in further detailbelow.

FIGS. 52A-52E are photographs of animal study results for a left eye ofthe fourth rabbit. FIG. 52A is after one week, FIG. 52B is after twoweeks, FIG. 52C is after three weeks, and FIGS. 52D and 52E are afterfour weeks. FIGS. 52A-52E illustrate an anterior capsulorhexis 5202, arefractive surface 5204 of an IOL, and IOL haptics 5208. The IOL haptics5208 are not visible in some figures, although the position of thehaptics may be assumed based on other figures and/or the position of anyvisible portions of the IOL flared radially outwardly to form the startof the haptics. Like several of the other left eyes, FIGS. 52A-52E showsignificant fibrosis and contraction. Due to the contraction andfibrosis, the effective diameter at which the left eye of FIGS. 52A-52Ecan take in light is about 2.6 mm, which significantly impairs thevision in that eye except under the best lighting conditions. FIG. 52Ealso shows PCO.

FIGS. 53A-53E are photographs of animal study results for a right eye ofa fifth rabbit. FIG. 53A is after one week, FIG. 53B is after two weeks,FIG. 53C is after three weeks, and FIGS. 53D and 53E are after fourweeks. FIGS. 53A-53E illustrate an anterior capsulorhexis 5302, arefractive surface 5304 of an IOL, an anterior opening 5306 of aprosthetic capsular device containing the IOL, and IOL haptics 5308. TheIOL haptics 5308 are not visible in some figures, although the positionof the haptics may be assumed based on other figures and/or the positionof any visible portions of the IOL flared radially outwardly to form thestart of the haptics Like FIGS. 49A-49E, FIGS. 53A-53E show goodcentering of the prosthetic capsular device in the natural capsular bag,and lack of fibrosis. FIG. 53E shows material 5312 on a posteriorsurface of the IOL and peripheral PCO 5314.

FIGS. 54A-54E are photographs of animal study results for a left eye ofthe fifth rabbit. FIG. 54A is after one week, FIG. 54B is after twoweeks, FIG. 54C is after three weeks, and FIGS. 54D and 54E are afterfour weeks. FIGS. 54A-54E illustrate an anterior capsulorhexis 5402, arefractive surface 5404 of an IOL, and IOL haptics 5408. The IOL haptics5408 are not visible in some figures, although the position of thehaptics may be assumed based on other figures and/or the position of anyvisible portions of the IOL flared radially outwardly to form the startof the haptics. Like several of the other left eyes, FIGS. 52A-52E showsignificant fibrosis and contraction. Due to the contraction andfibrosis, the effective diameter at which the left eye of FIGS. 54A-54Ecan take in light is about 4.5 mm, which significantly impairs thevision in that eye except under the best lighting condition.

The reduction in the effective diameter shows why PCO can be sodetrimental and preferably reduced or prevented. As described above, aNd:YAG laser may be used to ablate the natural capsular bag to removethe opaque membrane. If the natural capsular bag separating the vitreousis removed, then post-PCO treatment operation on an IOL absent aprosthetic capsular device could result in anterior flow of vitreous. Acareful user may be able to viscodissect an IOL from an eye and place aprosthetic capsular device comprising a posterior surface into the eyeto inhibit or prevent the flow of vitreous. The eye of a post-PCOsubject with an existing IOL issue may be salvageable using a prostheticcapsular device, providing another potential advantage and/or use.

One goal of the animal studies of FIGS. 45A-54E was to show that use ofa prosthetic capsular device was not worse for the eye than use of anIOL alone. The right eyes were all substantially free of fibrosis (e.g.,almost totally pristine), IOL position shift, and anterior capsulorhexiscontraction. By contrast, the left eyes generally showed significantfibrosis, IOL migration, and significant asymmetric contraction of thecapsulorhexis. The animal studies empirically show that the use of aprosthetic capsular device can provide at least some of the advantagesdiscussed herein.

Slight damage to the prosthetic capsular devices such as small tears inthe edge of the anterior opening may have occurred due to insertionthrough the Accuject 2.2 mm injectors. Upon any incomplete injection ofthe prosthetic capsular device into the natural capsular bag, theprosthetic capsular device was manipulated with a collar button hookafter injection to complete in-the-bag fixation. The manipulation and/ora hard push on the injector may have caused the damage. Injection of theprosthetic capsular device fully into the natural capsular bag (e.g.,without further manipulation or repositioning), for example using adifferent injector, may reduce the risk of tearing the prostheticcapsular device.

Inflammation of the vitreous in right eyes, starting after about twoweeks and then decreasing throughout the follow up, may have been due tothe material of the prosthetic capsular device being sterilized, but nothaving undergone an extensive extraction process such that uncrosslinkedsiloxane monomers can leach out of the material over time. Extractionprior to sterilization and packaging of the prosthetic capsular device,for example single, double, triple, or more extractions to promotecrosslinking (e.g., substantially total cros slinking), may reduce suchinflammation.

Fibrin formation between the prosthetic capsular device and the IOL mayhave been due to incomplete viscoelastic removal and/or residual OVDremained trapped behind the IOL. More aggressive viscoelastic evacuationafter the implantation, use of a more cohesive viscoelastic material,which may be easier to remove than dispersive viscoelastic materials,and/or an OVD removal technique may reduce the such fibrin formation.There was little change in the fibrin material throughout the fourweeks. Fibrin was also generally observed at the level of thecapsulorhexis edge in the left eyes, which was resolved within twoweeks.

Dilation or significant dilation of the natural capsular bag wasgenerally associated with the presence of the prosthetic capsulardevice. However, ACO was absent, for example due to lack of contactbetween the residual anterior capsule and the anterior surface of theprosthetic capsular device, such that the dilation was not a negativeresult.

The right eyes, in which a prosthetic capsular device was placed beforean IOL, showed significantly reduced Soemmering's ring formationcompared to the left eyes, in which only an IOL was placed. The righteyes showed reduced central and peripheral PCO compared to the lefteyes. A different edge profile (e.g., square) of a prosthetic capsulardevice, for example as described herein, may provide a better effectagainst PCO. PCO at week 4 of the examination was scored as a 0 in theright eyes and as 2±1 in the left eyes (two-tail P=0.01; t-Test: PairedTwo Sample for Means). ACO was found to be absent in the right eyes andwas mile (0.5 or 1) in the left eyes.

Central PCO was scored (two-tail P=0.05; t-Test: Paired Two Sample forMeans,) as 0.1±0.22 for right eyes and 1.2±0.75 for left eyes.Peripheral PCO was scored (two-tail P=0.23; t-Test: Paired Two Samplefor Means) as 0.8±0.83 for right eyes and 1.8±0.83 for left eyes; theamount of PCO varied from a trace to moderate PCO. Soemmering's ringformation was scored (two-tail P=0.006; t-Test: Paired Two Sample forMeans) as 2.8±0.83 for right eyes and 8.6±2.19 for left eyes; the lefteyes all showed a moderate Soemmering's ring formation withproliferation of cortical material in the periphery. In all cases, alower number indicates better results. In all parameters, eyes with aprosthetic capsular device scored better than eyes without a prostheticcapsular device.

All prosthetic capsular devices were found to be fully fixated inside ofthe natural capsular bag and centered. The IOL in FIGS. 45A-45E was veryslightly decentered inside of the prosthetic capsular device. Mild IOLdecentration (0.5 or 1) inside of the prosthetic capsular device wasobserved in two left eyes.

There was no sign of untoward inflammation or toxicity on any of theleft eyes. There was no sign of any toxicity or inflammation on four ofthe five right eyes. As mentioned above with respect to FIG. 47E, oneright eye showed a mild anterior vitritis.

Referring again to the disclosure regarding use of the technology deviceto control the properties of an IOL, FIG. 55A is a flowchart of anexample of controlling focus of an IOL using an external device.Starting at block 5500, the external device receives input from a userat block 5502. An example of user input is control of an external device(e.g., external to the eye) such as a smartwatch, smartphone, and thelike. In some implementations, control of the external device is with asecond external device. For example, a user wearing a ring on one handmay touch a smartwatch worn on the opposite wrist to complete a circuit,send a signal (e.g., via near-field communication (NFC)), or otherwisecommunicate. In some implementations, the user operation 5502 does notrequire full attention of the user (e.g., attention to a display) suchthat the focus can be controlled without the user deviating from anotheractivity such as driving or communicating with someone. For example, auser may initiate an operation by a series of taps on a smartwatch or avoice command based on built-in voice recognition such as Ski on Appledevices or OK Google on Android devices. In some implementations,features of a smartphone (e.g., volume buttons) and/or a smartwatch(e.g., a rotatable knob) can be manipulated, which may provide finetuning of and/or adjusting of the focus. Operation of a softwareapplication running on an external device that is configured to controlthe IOL is also possible.

Upon receipt of the user input at block 5502, the external devicewirelessly transmits an electronic message at block 5504 to the IOL. Thewireless transmission may be in accordance with a standard wirelessprotocol such as Bluetooth or a specialized wireless protocol, forexample to enhance security and/or safety. As described above, theexternal device may be a single device or a series of devices operatingin conjunction with each other. For example, the external device thatemits the wireless transmission at block 5504 may be a smartwatch. Foranother example, the external device that emits the wirelesstransmission at block 5504 may be a smartphone that received a firstwireless transmission from a smartwatch. The wireless transmission isconfigured to be received by a technology device and/or an IOLconfigured to process the wireless transmission and cause focusadjustment.

In some implementations, the wireless transmission is received by thetechnology device of the prosthetic capsular device, which then controlsoperation of an adjustable-focus IOL in the prosthetic capsular device.In some implementations, the wireless transmission is received by theadjustable-focus IOL in the prosthetic capsular device directly (e.g.,if the prosthetic capsular device lacks a suitable technology device orany technology device, or in the absence of the use of a prostheticcapsular device for suitable IOLs). In some implementations, thewireless transmission is received by another device that communicateswith the technology device of the prosthetic capsular device and/or theadjustable-focus IOL in the prosthetic capsular device. For example, thesmartwatch may send a wireless transmission to a smartphone, which emitsa secondary wireless transmission that may be received by the IOL, thetechnology device, etc. One or more of the wireless transmissions may besent over a network. Intraocular communication may be wireless (e.g.,based on the same or different wireless standard) or wired (e.g., basedon electrical contact between an exterior of the IOL haptics and aninterior of the prosthetic capsular device).

In response to the wireless transmission or a secondary wirelesstransmission, the IOL focus adjusts at block 5506. The block 5506 isshown in dashed outline because the process may be performed by anotherdevice (e.g., the IOL). The focus may adjust for near objects byincreasing refractive power (e.g., to allow the user to focus on nearobjects) and/or adjust for intermediate to distance vision by decreasingrefractive power (e.g., to allow the user to focus on intermediateand/or distant objects).

An example of an IOL that may be focus adjusted at block 5504 is ELENZASapphire from Elenza. Upon sensing a change in the natural pupil, theElenza IOL can accommodate, or focus. For example, upon sensing that thenatural pupil is constricting, the Elenza IOL can myopicallyaccommodate. As another example, upon sensing that the natural pupil isdilating, an IOL may return to the dis-accommodated state foremmetropia. As another example, upon sensing that the natural pupil isdilating, an IOL may return adjust focus for intermediate and/or distantobject viewing. In some implementations, the transmission at block 5506may effect accommodation regardless of a state of the natural pupil. Insome implementations, the transmission at block 5506 may effectaccommodation in combination with sensing of a change in a naturalpupil.

Another example of focus adjustment at block 5504 is by a technologydevice comprising an artificial pupil or electronically-controlled irisdiaphragm configured to selectively block light transmission into theeye. The transmission at block 5506 can instruct the artificial pupil toconstrict and/or dilate. In some implementations, an artificial pupilcould effectively work for patients with damaged or missing iris tissueand/or to provide increased depth of focus, creating a hyperfocality bydecreasing the effective aperture size. In some implementations, anartificial pupil allows the user to achieve better near and intermediatevision in adequate lighting, without the loss of distance vision. Anexample of a static device that could achieve these refractive benefitsis the Acufocus Kamra. This device is typically implanted either in thecornea or upon an IOL, and heretofore not been controllable by the user,for example in a manner that can increase or optimize functionality. Insome implementations, upon application of an electrical wirelesstransmission, the technology device works similarly to a cameraaperture, closing circumferentially from the limbal toward the visualaxis. In some implementations, upon application of an electricalwireless transmission, the molecular configuration of liquid crystals inthe technology device orient to make an edge opaque, akin to the resultof pupil constriction. The artificial pupil may work in combination withthe natural pupil, or may provide beneficial refractive effectsindependent of the natural pupil. In some implementations, an artificialpupil may work in combination with accommodation of an IOL such as theElenza IOL. In some implementations, a technology device of theprosthetic capsular device comprises the artificial pupil, which may beused in combination with an IOL, an accommodating IOL, or without anIOL.

Another example of an IOL that may be focus adjusted at block 5504 isLight Adjustable Lens (LAL) from Calhoun Vision that has not been lockedin. Upon application of an electrical wireless transmission, light isdirected to cause photopolymerization of macromers and swelling in anilluminated area, causing a change in power. The focus of the IOL may bechanged using a microsolenoid (e.g., application of an electricalwireless transmission to a coil creates a magnetic field that attractsor repels a magnetic material coupled to a refractive surface), MEMS(e.g., application of an electrical wireless transmission creates anelectrostatic charge that attracts a hinged metallic material coupled toa refractive surface), etc. The entire IOL or portions thereof (e.g., arefractive surface) may move within the prosthetic capsular device,providing a focusing mechanism to non-adjustable IOLs.

In some implementations, the IOL and/or the technology device may send awireless transmission, command instruction, computer-generated message,or the like to the external device to confirm that focus adjusted.Although the focus adjustment may be visible to a user, such feedbackmay aid in initial setup, calibration, troubleshooting, etc. In certainsuch implementations, the process may optionally further comprisereceipt of a confirmation wireless transmission by the external devicethat the focus was adjusted.

The external device may optionally be configured to receive otherwireless transmissions from the IOL and/or the technology device (e.g.,low battery, error codes, limits reached, etc.). In certain suchimplementations, the emission of the wireless transmission by theexternal device 5504 may be based on confirmation that the IOL is ableto focus in accordance with the wireless transmission. The externaldevice may optionally be configured to receive other wirelesstransmissions from the IOL and/or the technology device other thanregarding focus, for example as described in further detail herein.

The process ends at block 5508. The focus of the IOL may revert aftersome amount of time or in response to a second wireless transmissionfrom the external device (e.g., upon receipt of a second user input).Some of the processes discussed above and other processes are describedin more detail with respect to FIGS. 55B-55F.

FIG. 55B is a schematic of a system for controlling an electronic device(e.g., technology device and/or an IOL) using an external device. In theillustrated flowchart, a prosthetic capsular device 5510 includes atechnology device. The prosthetic capsular device 5510 at leastpartially contains an IOL 5512. The technology device of the prostheticcapsular device 5510 and/or the IOL 5512 is in communication with aprimary external device 5514. The primary external device 5514 maycomprise, for example, a smartphone, a smartwatch, etc. The primaryexternal device 5514 is optionally in communication with a secondaryexternal device 5516. The secondary external device 5516 may comprise,for example, a smartwatch (e.g., in combination with the primaryexternal device 5514 comprising a smartphone). The secondary externaldevice 5516 is optionally in communication with a tertiary externaldevice 5518. The tertiary external device 5518 may comprise, forexample, a ring (e.g., in combination with the secondary external device5516 comprising a smartwatch). The primary external device 5514, thesecondary external device 5516, and the tertiary external device 5518may act singly, in subcombination, or in full combination to, interalia, receive input by a user and emit a wireless transmission to thetechnology device of the prosthetic capsular device 5510 and/or the IOL5512. Additional external devices (e.g., quartenary, quinary, etc.) arealso possible.

FIG. 55C is a flowchart of an example method of controlling anelectronic device (e.g., technology device and/or an IOL) using anexternal device. Starting at block 5520, the external device receivesinput from a user at block 5522. Upon receipt of the user input at block5522, the external device processes the user input at block 5524. Theexternal device may include a processing module, a static memory module,a dynamic or temporary memory module, a power source, a user inputreceipt module, a wireless transmission emitting module, a wirelesstransmission receiving module, and the like. Upon processing of the userinput at block 5524, the external device generates an instructioncommand for transmission to an electronic device (e.g., a technologydevice of a prosthetic capsular device, an IOL, etc.) implanted in theeye at block 5526. The generation of the instruction command may beautomatic upon receipt and processing of the user input, or may includefurther interaction with the user or another device. The instructionsmay include, for example, to focus the IOL. Upon generation of theinstruction command at block 5526, the external device may optionallyreceive confirmation and/or a current status input from the electronicdevice (e.g., a technology device of a prosthetic capsular device, anIOL, etc.) implanted in the eye at block 5528. Depending on generationof the instruction command and/or receipt of the confirmation and/orcurrent status input from the electronic device, the process may repeatstarting at block 5522 or end at block 5530.

FIG. 55D is a flowchart of another example method of controlling anelectronic device (e.g., technology device and/or an IOL) using anexternal device. Referring to FIG. 55B, for example, the external devicecomprises a primary external device (e.g., a smartphone) and a secondaryexternal device (e.g., a smartwatch). Starting at block 5532, thesecondary external device receives input from a user at block 5534. Uponreceipt of the user input at block 5534, the secondary external devicecan be configured to process the user input (for example, a button pushor the like) and generate a signal based on the user input fortransmitting to the primary external device. The primary external devicecan be configured to receive the transmitted signal based on the userinput from the secondary external device at block 5536. The primaryexternal device may be in wired or wireless communication with thesecondary external device so as to receive the user input directly or asa result of a wireless transmission from the secondary external device.Upon receipt of the user input at block 5536, the primary externaldevice processes the user input at block 5538. Upon processing of theuser input at block 5538, the primary external device generates aninstruction command for transmission to an electronic device (e.g., atechnology device of a prosthetic capsular device, an IOL, etc.)implanted in the eye at block 5540. The generation of the instructioncommand may be automatic upon receipt and processing of the user input,or may include further interaction with the user, the secondary externaldevice, another device, etc. The instructions may include, for example,to focus the IOL. Upon generation of the instruction command at block5540, the primary external device may optionally receive confirmationand/or a current status input from the electronic device (e.g., atechnology device of a prosthetic capsular device, an IOL, etc.)implanted in the eye at block 5542. The primary external device and/orthe secondary external device may optionally display the confirmationand/or current status input at block 5544. Depending on generation ofthe instruction command, receipt of the confirmation and/or currentstatus input from the electronic device, and/or display of theconfirmation and/or current status input, the process may repeatstarting at block 5534 or end at block 5546.

FIG. 55E is a flowchart of another example method of controlling anelectronic device (e.g., technology device and/or an IOL) using anexternal device. Referring to FIG. 55B, for example, the external devicecomprises a primary external device (e.g., a smartphone) and a secondaryexternal device (e.g., a smartwatch). Starting at block 5550, thesecondary external device receives input from a user at block 5552. Uponreceipt of the user input at block 5552, the secondary external devicecan be configured to process the user input (for example, a button pushor the like) and generate a signal based on the user input fortransmitting to the primary external device. The primary external devicecan be configured to receive the transmitted signal generated based onthe user input from the secondary external device at block 5554. Theprimary external device may be in wired or wireless communication withthe secondary external device so as to receive the user input directlyor as a result of a wireless transmission from the secondary externaldevice. Upon receipt of the user input at block 5554, the primaryexternal device processes the user input at block 5556. Upon processingof the user input at block 5556, the primary external device generatesan instruction command for transmission to an electronic device (e.g., atechnology device of a prosthetic capsular device, an IOL, etc.)implanted in the eye at block 5558. The generation of the instructioncommand may be automatic upon receipt and processing of the user input,or may include further interaction with the user, the secondary externaldevice, another device, etc. The instructions may include, for example,to focus the IOL.

FIG. 55E includes a dashed horizontal line indicative of processes thatmay be performed by the electronic device (e.g., a technology device ofa prosthetic capsular device, an IOL, etc.) implanted in the eye. Itwill be appreciated that the electronic device may be separate from theexternal device, and that the processes described with respect to FIG.55E are examples for reference only. In some implementations, theexternal device and the electronic device form a system or kit.

The electronic device may receive the instruction command at block 5560.Upon receipt of the instruction command at block 5560, the electronicdevice may process the instruction command at block 5562. Uponprocessing of the instruction command at block 5562, the electronicdevice may adjust a parameter of the electronic device based on theinstruction command at block 5564. The adjustment of the parameter maybe automatic upon receipt and processing of the instruction command, ormay include further interaction with the user, the primary externaldevice, the secondary external device, and/or another device, analysisof the parameter and/or another parameter, etc. The parameter mayinclude, for example, IOL focus (e.g., an amount of masking, an amountof movement, an amount of rotation, etc.). Upon adjustment of theparameter at block 5564, the electronic device may generate confirmationand/or a current status output at block 5566. The electronic device mayperform more, fewer, different, differently ordered, etc. processes, mayinclude interaction between multiple electronic devices (e.g., between atechnology device of a prosthetic capsular device and an IOL), etc.

The primary external device may optionally receive confirmation and/or acurrent status input (generated as output) from the electronic deviceimplanted in the eye at block 5568. The primary external device and/orthe secondary external device may optionally display the confirmationand/or current status input at block 5570. The process ends at block5572.

FIG. 55F is a flowchart of another example method of controlling anelectronic device (e.g., technology device and/or an IOL) using anexternal device. Referring to FIG. 55B, for example, the external devicecomprises a primary external device (e.g., a smartphone) and a secondaryexternal device (e.g., a smartwatch). Starting at block 5574, thesecondary external device receives input from a user at block 5576. Uponreceipt of the user input at block 5576, the secondary external devicecan be configured to process the user input (for example, a button pushor the like) and generate a signal based on the user input fortransmitting to the primary external device. The primary external devicecan be configured to receive the transmitted signal generated based onthe user input from the secondary external device at block 5578. Theprimary external device may be in wired or wireless communication withthe secondary external device so as to receive the user input directlyor as a result of a wireless transmission from the secondary externaldevice.

The primary external device determines the user input at block 5580. Inthe event of a first user input, the primary external device generatesan instruction command to change focus to near objects (e.g., myopicaccommodation as described herein with respect to the Elenza IOL) atblock 5582. In the event of a second user input different than the firstuser input, the primary external device generates an instruction commandto change focus to intermediate and/or distant objects (e.g., emmetropiaor a dis-accommodated state as described herein) at block 5584. Forclarity, the Elenza IOL uses pupillary constriction as a sign that theeye is trying to accommodate (focus) and the lens changes focus based onthe natural pupillary constriction. That is, the Elenza IOL does notcause the pupil to constrict and does not contain a prosthetic irisdevice. In some implementations, instruction commands described hereincould, for example, cause the Elenza IOL to change focus regardless ofconstriction of the natural pupil.

In some implementations, for example using an IOL other than an ElenzaIOL or by way of a technology device of a prosthetic capsular device, aninstruction command could, for example, effect constriction or dilationof an artificial pupil.

Focus adjustment of an Elenza IOL and constriction/dilation of anartificial pupil and are provided as example parameter changes, and itwill be appreciated that other parameter changes based on differentinputs is also possible. The generation of the instruction commands maybe automatic upon receipt and processing of the user input, or mayinclude further interaction with the user (e.g., instruction command incombination with sensing of natural pupil dilation), the secondaryexternal device, another device, etc. In some implementations, thesecondary external device may determine the user input and the primaryexternal device may receive an instruction command.

Upon generation of the instruction command at block 5582 or 5584, theprimary external device transmits the instruction command to anelectronic device (e.g., a technology device of a prosthetic capsulardevice, an IOL, etc.) implanted in the eye at block 5586. Theinstructions may include, for example, to focus the IOL. Upontransmission of the instruction command at block 5586, the primaryexternal device may optionally receive confirmation and/or a currentstatus input from the electronic device (e.g., a technology device of aprosthetic capsular device, an IOL, etc.) implanted in the eye at block5588. The primary external device and/or the secondary external devicemay optionally display the confirmation and/or current status input atblock 5590. The process ends at block 5592.

FIG. 56 is a block diagram depicting an example computer hardware systemconfigured to execute software for implementing one or moreimplementations of electronic device control disclosed herein In someimplementations, the hardware systems and/or devices described abovetake the form of a computing system 5600, which is a block diagram ofone implementation of a computing system that is in communication withone or more computing systems 5618 and/or one or more data sources 5620via one or more networks 5616. The computing system 5600 may be used toimplement one or more of the systems and methods described herein. Insome implementations, the computing system 5600 is configured to manageaccess or administer a software application. While FIG. 56 illustratesan example computing system 5600, it is recognized that thefunctionality provided for in the components and modules of thecomputing system 5600 may be combined into fewer components and modulesor further separated into additional components and modules.

Electrical System

In some implementations, the computing system 5600 comprises anelectrical system 5606 configured to carry out one or more of thefunctions described herein with reference to control of an electronicdevice implanted in an eye, including any one of techniques describedabove. The electrical system 5606 and/or other modules may be executedon the computing system 5600 by a central processing unit 5602 discussedfurther below.

In general, the word “module,” as used herein, refers to logic embodiedin hardware or firmware, or to a collection of software instructions,possibly having entry and exit points, written in a programminglanguage, such as, for example, COBOL, CICS, Java, Lua, C or C++. Asoftware module may be compiled and linked into an executable program,installed in a dynamic link library, or may be written in an interpretedprogramming language such as, for example, BASIC, Perl, or Python. Itwill be appreciated that software modules may be callable from othermodules or from themselves, and/or may be invoked in response todetected events or interrupts. Software instructions may be embedded infirmware, such as an EPROM. It will be further appreciated that hardwaremodules may be comprised of connected logic units, such as gates andflip-flops, and/or may be comprised of programmable units, such asprogrammable gate arrays or processors. The modules described herein arepreferably implemented as software modules, but may be represented inhardware or firmware. Generally, the modules described herein refer tological modules that may be combined with other modules or divided intosub-modules despite their physical organization or storage.

Computing System Components

The computing system 5600 can comprise a central processing unit (CPU)5602, which may comprise a conventional microprocessor. The computingsystem 5600 further comprises a memory 5604, such as random accessmemory (RAM) for temporary storage of information and/or a read onlymemory (ROM) for permanent storage of information, and a mass storagedevice 5608, such as a hard drive, diskette, or optical media storagedevice. In some implementations, the modules of the computing system5600 are connected to the computer using a standards based bus system.In some implementations, the standards-based bus system could includePeripheral Component Interconnect (PCI), Microchannel, SCSI, IndustrialStandard Architecture (ISA) and Extended ISA (EISA) architectures, forexample.

The computing system 5600 comprises one or more commonly availableinput/output (I/O) devices and interfaces 5612, such as a keyboard,mouse, touchpad, touchscreen, ring, printer, etc. In someimplementations, the I/O devices and interfaces 5612 comprise one ormore display devices, such as a monitor or touchscreen, that allows thevisual presentation of data to a user. A display device can provide forthe presentation of graphical user interfaces (GUI), applicationsoftware data, and multimedia presentations, for example. In someimplementations, the I/O devices and interfaces 5612 comprise amicrophone, motion, and/or NFC sensor that allows a user to generateinput to the computing system 5600 using sounds, voice, motion,gestures, or the like. In FIG. 56, the I/O devices and interfaces 5612also provide a communications interface to various external devices viaa link 5614 to the network 5616. The computing system 5600 may alsocomprise one or more multimedia devices 5610, such as speakers, videocards, graphics accelerators, and microphones, for example.

Computing System Device/Operating System

The computing system 5600 may run on a variety of computing devices,such as, for example, a specifically designed device, a server, aWindows server, a Structure Query Language server, a Unix server, apersonal computer, a mainframe computer, a laptop computer, a tabletcomputer, a cellular phone, a smartphone, a smartwatch, a personaldigital assistant, a kiosk, an audio player, an e-reader device, and soforth. The computing system 5600 is generally controlled and coordinatedby operating system software, such z/OS, Windows 95, Windows 98, WindowsNT, Windows 2000, Windows XP, Windows Vista, Windows 7, Windows 8,Linux, BSD, SunOS, Solaris, Android, iOS, BlackBerry OS, or othercompatible operating systems. In Macintosh systems, the operating systemmay be any available operating system, such as MAC OS X. In someimplementations, the computing system 5600 is controlled by aproprietary operating system. The operating system may, for example,control and schedule computer processes for execution, perform memorymanagement, provide file system, networking, and I/O services, andprovide a user interface, such as a GUI, among other things.

Network

FIG. 56 illustrates the computing system 5600 is coupled to an optionalnetwork 5616, such as a LAN, WAN, or the Internet, for example, via awired, wireless, or combination of wired and wireless, communicationlink 5614. The network 5616 communicates with various computing devicesand/or other electronic devices via wired or wireless communicationlinks. In FIG. 56, the network 5616 is communicating with one or morecomputing systems 5618 and/or one or more data sources 5620.

Access to the electrical system 5606 of the computer system 5600 bycomputing systems 5618 and/or by data sources 5620 may be through aweb-enabled user access point such as the computing systems' 5618 ordata source's 5620 personal computer, mobile device, cellular phone,smartphone, smartwatch, laptop, tablet computer, e-reader device, audioplayer, or other device capable of connecting or configured to connectto the network 5616. Such a device may have a browser module or specificapplication that is implemented as a module that uses text, graphics,audio, video, and other media to present data and to allow interactionwith data via the network 5616.

The browser module or specific application may be implemented as acombination of an all points addressable display such as a cathode-raytube (CRT), a liquid crystal display (LCD), a plasma display, or othertypes and/or combinations of displays. The browser module or specificapplication may be implemented to communicate with input devices 5612and may comprise software with the appropriate interfaces to allow auser to access data through the use of stylized screen elements such as,for example, menus, windows, dialog boxes, toolbars, and controls (forexample, radio buttons, check boxes, sliding scales, and so forth). Thebrowser module may communicate with a set of input and output devices toreceive wireless transmissions from the user.

The input device(s) may comprise a keyboard, roller ball, pen andstylus, mouse, ring, smartwatch, knob, trackball, voice recognitionsystem, or pre-designated switches or buttons. The output device(s) maycomprise a speaker, a display screen, a printer, or a voice synthesizer.A touch screen may act as a hybrid input/output device. In someimplementations, a user may interact with the system through a systemterminal without communications over the Internet, a WAN, or LAN, orsimilar network.

In some implementations, the system 5600 comprises a physical or logicalconnection between a remote microprocessor and a mainframe host computerfor the purpose of uploading, downloading, or viewing interactive dataand databases on-line in real time. The remote microprocessor may beoperated by an entity operating the computer system 5600, including theclient server systems or the main server system, an/or may be operatedby one or more of the data sources 5620 and/or one or more of thecomputing systems 5618. In some implementations, terminal emulationsoftware may be used on the microprocessor for participating in themicro-mainframe link.

In some implementations, computing systems 5618 that are internal to anentity operating the computer system 5600 may access the electricalsystem 5606 internally as an application or process run by the CPU 5602.

User Access Point

In some implementations, a user access point or user interface comprisesa personal computer, a laptop computer, a tablet computer, an e-readerdevice, a mobile device, a cellular phone, a smartphone, a smartwatch, aGPS system, a Blackberry® device, a portable computing device, a server,a computer workstation, a local area network of individual computers, aninteractive kiosk, a personal digital assistant, an interactive wirelesscommunications device, a handheld computer, an embedded computingdevice, an audio player, or the like.

Other Systems

In addition to the systems illustrated and described above, the network5616 may communicate with other data sources and/or other computingdevices. The computing system 5600 may comprise one or more internaland/or external data sources. In some implementations, one or more ofthe data repositories and the data sources may be implemented using arelational database, such as DB2, Sybase, Oracle, CodeBase, Microsoft®SQL Server, as well as other types of databases such as, for example, aflat file database, an entity-relationship database, and object-orienteddatabase, and/or a record-based database.

FIG. 73A illustrates an anterior side perspective view of an exampleprosthetic capsular device 7300 in an unfolded state. FIG. 73Billustrates an anterior plan view of the example prosthetic capsulardevice 7300 of FIG. 73A in an unfolded state. FIG. 73C illustrates aside view of the example prosthetic capsular device 7300 of FIG. 73A inan unfolded state. The device 7300 comprises a plurality of segments orleaves or petals 7302 spaced by gaps 7304. The device 7300 optionallycomprises an optic 7310. As best seen in FIGS. 73A and 73C, the devices7300 is substantially flat or planar or two-dimensional in a first orunfolded state or configuration, which can increase ease ofmanufacturing versus a device that is three-dimensional in an unfoldedstate.

Referring again to FIGS. 73B and 73C, certain example dimensions of thedevice 7300 in the unfolded state are provided. In some implementations,the device 7300 has a diameter 7320, including the petals, between about10 mm and about 20 mm (e.g., about 10 mm, about 11 mm, about 12 mm,about 13 mm, about 14 mm, about 15 mm, about 16 mm, about 17 mm, about18 mm, about 19 mm, about 20 mm, ranges between such values, etc.). Insome implementations, the device 7300 has a diameter 7322, excluding thepetals, between about 5 mm and about 15 mm (e.g., about 5 mm, about 6mm, about 7 mm, about 8 mm, about 9 mm, about 10 mm, about 11 mm, about12 mm, about 13 mm, about 14 mm, about 15 mm, ranges between suchvalues, etc.). In some implementations, the circumferential width 7324of a petal 7302 is between about 20° and about 30° (e.g., about 20°,about 21°, about 22°, about 23°, about 24°, about 25°, about 26°, about27°, about 28°, about 29°, about 30°, ranges between such values, etc.).In some implementations, the circumferential width 7326 of a gap 7304 isbetween about 20° and about 30° (e.g., about 20°, about 21°, about 22°,about 23°, about 24°, about 25°, about 26°, about 27°, about 28°, about29°, about 30°, ranges between such values, etc.). In someimplementations, a ratio of the circumferential width 7326 of a petal7302 to a circumferential width 7328 of a gap 7304 is between about 1:2and about 2:1 (e.g., about 1:2, about 5:8, about 2:3, about 7:8, about15:16, about 25:26, about 1:1, about 8:7, about 16:15, about 26:25,about 3:2, about 8:5, about 2:1, ranges between such values, etc.). Insome implementations, a diameter 7328 of the optic 7310 is between about4 mm and about 10 mm (e.g., about 4 mm, about 5 mm, about 6 mm, about 7mm, about 8 mm, about 9 mm, about 10 mm, ranges between such values,etc.). In some implementations, a thickness 7330 of the device 7300except the optic 7310, or a petal 7302, is between about 0.1 mm andabout 0.5 mm (e.g., about 0.1 mm, about 0.15 mm, about 0.2 mm, about0.25 mm, about 0.3 mm, about 0.35 mm, about 0.4 mm, about 0.45 mm, about0.5 mm, ranges between such values, etc.).

The unfolded device 7300 may be folded for insertion into a naturalcapsular bag. The two-dimensional nature of the unfolded device 7300 mayallow further folding, for example compared to a three-dimensionalstructure, which can allow insertion through a smaller incision. In someimplementations, the size of the incision is solely determined by theIOL to be placed in the capsular device, as the device can be insertedthrough an incision smaller than any known IOL.

FIG. 73D illustrates an anterior plan view of the example prostheticcapsular device 7300 of FIG. 73A in a folded state. FIG. 73E illustratesan anterior side perspective view of the example prosthetic capsulardevice 7300 of FIG. 73A in a folded state. As the device 7300 isinserted into a natural capsular bag, the device may unfold towards itsunfolded state. The optic 7310 may contact the posterior side of thenatural capsular bag. The petals 7302 may fold towards the anterior andthen radially inwardly, eventually folding in upon themselves. Thefolded device 7300 comprises an anterior opening 7312 through which anIOL may be inserted. The device 7300 is configured to contain an IOL.

The folded device 7300 may include other features described herein, forexample electronic devices, tabs, ring structures, etc. In someimplementations, the two-dimensional nature of the unfolded device 7300may allow easier manufacturing of such features. For example, a flexcircuit may be patterned on a first side of the device 7300 that isconfigured to be an interior of the capsular device 7300. For anotherexample, ring haptics or tabs may be patterned on a second side of thedevice 7300 that is configured to be an exterior of the capsular device7300. For yet another example, openings and/or anchor points can beformed on one or both sides of the device 7300.

While the methods and devices described herein may be susceptible tovarious modifications and alternative forms, specific examples thereofhave been shown in the drawings and are herein described in detail. Itshould be understood, however, that the invention is not to be limitedto the particular forms or methods disclosed, but, to the contrary, theinvention is to cover all modifications, equivalents, and alternativesfalling within the spirit and scope of the various implementationsdescribed and the appended claims. Further, the disclosure herein of anyparticular feature, aspect, method, property, characteristic, quality,attribute, element, or the like in connection with an implementation orembodiment can be used in all other implementations or embodiments setforth herein. Any methods disclosed herein need not be performed in theorder recited. The methods disclosed herein may include certain actionstaken by a practitioner; however, the methods can also include anythird-party instruction of those actions, either expressly or byimplication. For example, actions such as “inserting an intraocular lensinto a prosthetic capsular device” include “instructing the insertion ofan intraocular lens into a prosthetic capsular device.” The rangesdisclosed herein also encompass any and all overlap, sub-ranges, andcombinations thereof. Language such as “up to,” “at least,” “greaterthan,” “less than,” “between,” and the like includes the number recited.Numbers preceded by a term such as “about” or “approximately” includethe recited numbers and should be interpreted based on the circumstances(e.g., as accurate as reasonably possible under the circumstances, forexample ±5%, ±10%, ±15%, etc.). For example, “about 3.5 mm” includes“3.5 mm.” Phrases preceded by a term such as “substantially” include therecited phrase and should be interpreted based on the circumstances(e.g., as much as reasonably possible under the circumstances). Forexample, “substantially constant” includes “constant.” Unless statedotherwise, all measurements are at standard conditions includingtemperature and pressure.

What is claimed is:
 1. A prosthetic capsular device for insertion into anatural capsular bag of an eye after removal of a cataract, the devicecomprising a housing configured to receive at least one of anintraocular lens (IOL) and/or a technology device secured within saidhousing; the housing having a compatible shape to the shape of a naturalcapsular bag of an eye and comprising: an anterior central openinghaving a first perimeter capable of allowing at least one or more ofinsertion, removal, or replacement of the at least one of an intraocularlens (IOL) and/or a technology device, the anterior opening surroundedby a continuous anterior wall defining a capsular-engaging surface,wherein the anterior central opening is configured to receive a secondintraocular lens (IOL) for positioning in or on the anterior centralopening, wherein the second IOL substantially encloses the anteriorcentral opening upon securement therein; a posterior central openinghaving a second perimeter configured to accommodate a distinctrefractive surface, the posterior opening surrounded by a continuousposterior wall defining a capsular-engaging surface; a first arc-shapedopening located radially outward of the posterior central opening on thecontinuous posterior wall, wherein the first arc-shaped opening extendsthrough a thickness of the continuous posterior wall; a secondarc-shaped opening located radially outward of the posterior centralopening on the continuous posterior wall, wherein the second arc-shapedopening extends through the thickness of the continuous posterior wall,wherein each of the first and second arc-shaped openings has a widthbetween 0 mm and 2 mm, wherein the first arc-shaped opening is a mirrorimage of the second arc-shaped opening along a major axis of theprosthetic capsular device, and wherein the arc-shaped opening is amirror image of the second arc-shaped opening along a minor axis of theprosthetic capsular device; a curvilinear, solid, and discoidalcontinuous equatorial portion interposed amid the continuous anteriorwall and the continuous posterior wall and defining a capsular-engagingsurface, wherein the continuous anterior wall and the continuousposterior wall extend to the continuous equatorial portion, wherein thecontinuous anterior wall, continuous posterior wall, and continuousequatorial portion are integrally formed as a single-piece structure,wherein the continuous anterior wall, continuous posterior wall, andcontinuous equatorial portion substantially enclose the housing exceptat said anterior central opening and posterior central opening; ananterior transition point positioned between the continuous equatorialportion and the anterior central opening, the anterior transition pointdividing the continuous anterior wall into an anterior straight-walledportion and a radially inner anterior portion, wherein the anteriorstraight-walled portion is substantially orthogonal to the continuousanterior wall; a posterior transition point positioned between thecontinuous equatorial portion and the posterior central opening, theposterior transition point dividing the continuous posterior wall into aposterior straight-walled portion and a radially inner posteriorportion, wherein the posterior straight-walled portion is substantiallyorthogonal to the continuous posterior wall; and an inflection point,wherein the inflection point is defined between the continuousequatorial portion and the anterior central opening, the inflectionpoint dividing the continuous anterior wall into a radially inneranterior concavity portion that is concave toward an interior of thehousing and a radially outer anterior concavity portion that is concaveaway from the interior of the housing; and a distinct refractive surfaceconfigured to be inserted into the housing and directly secured to theposterior central opening after the housing is inserted in the eye,wherein the distinct refractive surface substantially encloses theposterior central opening upon securement therein, wherein dimensions ofthe prosthetic capsular device closely matches dimensions of the naturalcapsular bag of the eye in which the cataract has been removed, whereinthe continuous equatorial portion protrudes radially beyond the anteriorstraight-walled portion and the posterior straight-walled portionrelative to a longitudinal axis of the housing, wherein the radiallyinner anterior portion tapers radially inwardly toward the anteriorcentral opening, wherein the continuous equatorial portion comprises athird perimeter defined relative to the longitudinal axis, the thirdperimeter being greater than the first and second perimeters such that acontinuous cavity is at least partially defined by the continuousanterior wall, the continuous posterior wall, and the continuousequatorial portion, wherein the continuous cavity is configured toaccommodate the at least one of an intraocular lens (IOL) and/or atechnology device, wherein the housing is self-expandable when insertedinto the natural capsular bag of the eye, wherein the anterior centralopening comprises a diameter ranging from about 5 mm to about 7 mm, andwherein the housing does not comprise haptics.
 2. The prostheticcapsular device of claim 1, wherein each of the first and secondarc-shaped openings comprises an arc between 30° and 120°.
 3. Theprosthetic capsular device of claim 1, wherein each of the first andsecond arc-shaped openings comprises a slit.
 4. The prosthetic capsulardevice of claim 1, wherein the housing comprises one or more ofsilicone, hydrogel, collamer, acrylic, or acrylic derivatives.
 5. Theprosthetic capsular device of claim 1, wherein the distinct refractivesurface has a refractive power between −35 D and +35 D.
 6. Theprosthetic capsular device of claim 1, wherein the distinct refractivesurface has a refractive power less than −35 D.
 7. The prostheticcapsular device of claim 1, wherein the distinct refractive surface hasa refractive power greater than +35 D.
 8. The prosthetic capsular deviceof claim 1, wherein the housing further comprises: a third arc-shapedopening located radially outward of the anterior central opening on thecontinuous anterior wall, wherein the third arc-shaped opening extendsthrough a thickness of the continuous anterior wall; and a fourtharc-shaped opening located radially outward of the anterior centralopening on the continuous anterior wall, wherein the fourth arc-shapedopening extends through the thickness of the continuous anterior wall.9. The prosthetic capsular device of claim 1, wherein the housingcomprises a posterior fin.
 10. The prosthetic capsular device of claim1, wherein the prosthetic capsular device is symmetric about thelongitudinal axis and a transverse axis.
 11. The prosthetic capsulardevice of claim 1, wherein a distance between the continuous anteriorwall and the continuous posterior wall is between about 1.5 mm and about5.5 mm.
 12. The prosthetic capsular device of claim 1, wherein theradially inner posterior portion tapers radially inwardly toward theposterior central opening.
 13. The prosthetic capsular device of claim1, wherein the distinct refractive surface in the posterior centralopening is an intraocular lens (IOL).
 14. The prosthetic capsular deviceof claim 1, wherein the technology device provides at least one ofbiometric measurement functions, computer functions, image generationand projection onto the retina, or internet/WiFi capabilities.
 15. Theprosthetic capsular device of claim 1, wherein the technology device isused to control at least one property of the intraocular lens (IOL). 16.The prosthetic capsular device of claim 1, wherein the housing comprisesa material configured to shield the eye from electromagnetic waves orheat generated by the technology device.
 17. The prosthetic capsulardevice of claim 1, wherein the housing comprises a transparent material.18. The prosthetic capsular device of claim 1, wherein the housingcomprises an internal lip.
 19. The prosthetic capsular device of claim1, wherein the internal lip is configured to hold the IOL and/ortechnology device.
 20. The prosthetic capsular device of claim 1,wherein the housing is deformable so as to be folded and inserted via aninjection system.